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June 29, 2010
InteKrin Therapeutics Presented Phase 2b Clinical Data at the 2010 American Diabetes Association Annual Meeting, Demonstrating Improved Glycemic Control in Patients with Type 2 Diabetes Without Causing the Edema Seen with Pioglitazone

Los Altos, CaliforniaTuesday, June 29, 2010—InteKrin Therapeutics presented 6 month Phase 2b clinical data for edema in diabetic patients showing differentiation for INT131, a Selective PPAR-gamma Modulator (SPPARM), from Actos® (pioglitazone), yesterday at the American Diabetes Association annual meeting in Orlando, FL.

INT131 besylate (INT131) is a novel, non-TZD, selective oral PPAR-gamma modulator (SPPARM) designed to improve glucose metabolism while minimizing the side effects of the TZD full PPAR-gamma agonists such as Actos®: fluid retention (edema), CHF, bone fracture, and weight gain. The Phase 2b trial, INT131-007, was a 366 patient 24 wk double blind study comparing 4 doses of INT131 to maximal dose Actos® (pioglitazone) or placebo in patients with poorly controlled T2DM on stable dose sulfonylurea (SU) with or without metformin (met). Lower extremity edema was assessed with a predefined scoring tool designed for maximal sensitivity for pitting edema at baseline, 12, and 24 wks. Results show INT131 improved glycemic control as measured by HbA1c comparable to Actos® but without evidence of any significant change in edema compared to baseline or placebo. Substantial edema was noted in the pioglitazone group, consistent with published data. These findings support the SPPARM function of INT131 and suggest it represents a safer insulin sensitizer.

“This data clearly differentiates INT131 besylate from pioglitazone with respect to the important clinical parameter of edema,” remarked Dr. Alex DePaoli, Acting Chief Medical Officer of InteKrin Therapeutics, who presented the data. “These findings are consistent with previous clinical data and support the advantages of the SPPARM nature of this agent.”

“Insulin sensitization is a core therapeutic mechanism for addressing the Type 2 Diabetes epidemic,” added Dr. Linda Higgins, President & Chief Executive Officer of InteKrin Therapeutics. “INT131 besylate offers a potential significant advance in addressing the critical need for a safe insulin sensitizer.”


About INT131

INT131 is a next-generation insulin sensitizer that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of Type 2 Diabetes. As a selective PPAR-gamma modulator (SPPARM), INT131 has been designed to provide potent glucose lowering and durability of effect without the recognized side effects of the currently available insulin sensitizers which, unlike INT131, are full PPAR-gamma agonists. InteKrin has completed an End-Of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for INT131 and is moving the program into Phase 3 development.

About InteKrin (www.InteKrin.com)
InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.

To learn more about InteKrin, visit www.InteKrin.com.

Contact:
Heather Zimmerman
InteKrin Therapeutics Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501
SOURCE: InteKrin Therapeutics Inc.

June 18, 2010
InteKrin Therapeutics to Present Phase 2b Clinical Data for Edema at the 2010 American Diabetes Association Annual Meeting

Los Altos, CaliforniaFriday, June 18, 2010—InteKrin Therapeutics Inc. announced today it will present 6 month Phase 2b clinical data for edema in diabetic patients showing differentiation for INT131, a Selective PPAR-gamma Modulator (SPPARM), from Actos® pioglitazone, at the American Diabetes Association annual meeting in Orlando, FL, Monday, June 28, 2010 at 2:45 pm EDT during the “Update on BARI 2D --Treatment of Insulin Resistance” session.

Dr. Alex DePaoli, Acting Chief Medical Officer of InteKrin Therapeutics, will present “INT131 Besylate, a Selective PPAR-gamma Modulator (SPPARM), Improved Glycemic Control in Patients with Type 2 Diabetes without Causing the Edema Seen with Pioglitazone.”

About INT131

INT131 is a next-generation insulin sensitizer that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of Type 2 Diabetes. As a selective PPAR-gamma modulator (SPPARM), INT131 has been designed to provide potent glucose lowering and durability of effect without the recognized side effects of the currently available insulin sensitizers which, unlike INT131, are full PPAR-gamma agonists. InteKrin has completed an End-Of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for INT131 and is moving the program into Phase 3 development.

About InteKrin (www.InteKrin.com)
InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.

To learn more about InteKrin, visit www.InteKrin.com.

Contact:
Heather Zimmerman
InteKrin Therapeutics Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501
SOURCE: InteKrin Therapeutics Inc.

May 10, 2010
InteKrin Therapeutics Appoints Linda Higgins, PhD as President and Chief Executive Officer. Company Founder Denny Lanfear named Chairman of the Board.

Los Altos, CaliforniaMonday, May 10, 2010—InteKrin Therapeutics Inc. announced today that Linda Slanec Higgins, PhD has been named President and Chief Executive Officer. Since joining InteKrin in early 2007 Linda has had increasing responsibilities in key areas including Product Development, CMC and Regulatory Affairs; she most recently served as Chief Scientific Officer and Chief Operating Officer.

“Linda’s contributions to InteKrin’s progress have been extraordinarily impactful and critical to our success,” said Denny Lanfear, InteKrin Founder, former President and Chief Executive Officer. “Her leadership and capabilities have allowed us to move INT131 forward from Phase 2 to Phase 3 over the past three years, and will serve her well as we take InteKrin and INT131 forward.”

“I look forward to working with the outstanding InteKrin team to move INT131 into Phase 3” said Dr. Higgins. “As we prepare for the future we will continue to develop the company in key areas. InteKrin is dedicated to advancing therapies for significant medical needs, and we are excited about the potential of INT131 to offer Type 2 Diabetes patients a safer treatment for insulin resistance.”

Mr. Lanfear has been named Chairman of the Board. Under Mr. Lanfear’s five year leadership the company has been taken from inception through a successful End-Of-Phase-2 meeting with the FDA and into Phase 3 with a major therapeutic area lead product of high market potential. “This management transition is part of InteKrin’s plans to continue to develop the organization consistent with the future mission. I look forward to supporting Dr. Higgins and her team as they address the challenges ahead” commented Mr. Lanfear.

About INT131

INT131 is a next-generation insulin sensitizer currently in Phase 2b testing that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of type 2 diabetes. Treating and improving insulin sensitivity in diabetic patients by activating PPAR-gamma is an important therapeutic tool for physicians, providing powerful glucose control and durability of effect. As a SPPARM, INT131 selectively modulates PPAR-gamma, thereby enabling the separation of PPAR gamma anti-diabetic efficacy from the well recognized TZD side effects.

About InteKrin (www.InteKrin.com)
InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.

To learn more about InteKrin, visit www.InteKrin.com.

Contact:
Heather Zimmerman
InteKrin Therapeutics Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501
SOURCE: InteKrin Therapeutics Inc.

April 22, 2010
InteKrin Therapeutics Appoints Roman Skowronski, MD, PhD as Vice President of Clinical Development

Los Altos, California—April 22, 2010— InteKrin Therapeutics Inc., a clinical stage biopharmaceutical company focused on the development of products for diabetes, metabolism and obesity, today announced the appointment of Roman Skowronski, MD, PhD, to the position of Vice President, Clinical Development. Dr. Skowronski will be a member of InteKrin’s senior management team and will be responsible for the Phase 3 clinical development of InteKrin’s lead compound, INT131 besylate.

“We are extremely pleased to have a seasoned drug developer of Dr. Skowronski’s caliber join the company,” said Denny Lanfear, InteKrin Chief Executive. “Roman joins us as we prepare to initiate the Phase 3 program for our lead compound INT131, a non-TZD selective PPAR-gamma modulator (SPPARM) for safe treatment of insulin resistance in Type 2 diabetics. The addition of such a highly experienced drug developer and clinician to the team is very positive for the Company.”

“I am thrilled to be joining the team at InteKrin and to have the opportunity to advance INT131 into Phase 3,” said Dr. Skowronski. “The Phase 2b results show that INT131 could be a significant clinical advancement in the treatment of Type 2 Diabetes. Insulin resistance is the key etiological feature to the onset and subsequent progression of the disease and as a true SPPARM, INT131 promises insulin sensitization benefits without the edema, fluid retention and weight gain exhibited by the TZDs.”

Dr. Skowronski brings over 15 years of extensive experience in clinical research and development of small molecules and biopharmaceutics delivered through oral, transdermal, inhalation, and implantable modes. Most recently Dr. Skowronski was a VP of Clinical Development at AcelRx. Previously Dr. Skowronski served in leadership positions at ALZA, a Johnson & Johnson company, and Alexza, where he was responsible for the clinical development of several programs in the area of endocrinology, urology, oncology, reproductive medicine and pain management,including successful approval and commercialization of several products. Dr. Skowronski received his MD and PhD degrees from the Medical University Gdansk, Poland and completed postdoctoral fellowships in the Departments of Medicine at the University of California San Diego and Stanford University focused on endocrine and diabetes clinical research.

 

About InteKrin (www.InteKrin.com)

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.


To learn more about InteKrin, visit www.InteKrin.com.


Contact:
Heather Zimmerman
InteKrin Therapeutics Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics Inc


February 8, 2010
InteKrin Therapeutics’ Co-Founder Receives Appointment as Professor of Medicine at Harvard Medical School

Los Altos, California—Monday, February 8, 2009— InteKrin Therapeutics Inc announced today that the Company’s co-founder and Scientific Advisory Board Chairman, Christos Mantzoros, M.D., DSc., FACP, FACE, has been appointed Professor of Medicine at Harvard Medical School and Professor in Environmental Health at the Harvard School of Public Health.

Dr. Mantzoros is a member of Harvard’s Division of Endocrinology, Diabetes, and Metabolism, and is an acknowledged expert in the fields of insulin resistance, body weight regulation, adipokine biology, and energy homeostasis. He has published more than 200 original papers and more than 100 reviews and chapters which have received more than 12,000 citations. He has received several national and international awards and has also been elected a member of The American Society for Clinical Investigation (ASCI).

Dr. Mantzoros, who trained at Harvard, serves as Founding Director of the Human Nutrition Research Unit and as the Clinical Research Overseer at Beth Israel Deaconess Medical Center and the Joslin Diabetes Center. In conjunction with his new appointment, he will also be assuming responsibilities as Chief of Endocrinology and Diabetes at the Greater Boston VA Healthcare System, a system of three hospitals and six outpatient clinics in the greater Boston area which are affiliated with Harvard Medical School.

Dennis M. Lanfear, President and Chief Executive Officer, and Dr. Mantzoros founded InteKrin Therapeutics Inc in 2005. Dr. Mantzoros remains an integral part of InteKrin Therapeutics’ management team and regularly advises on scientific matters.

 

About InteKrin (www.InteKrin.com)

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.


To learn more about InteKrin, visit www.InteKrin.com.


Contact:
Heather Zimmerman
InteKrin Therapeutics Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics Inc


January 11, 2010
InteKrin Therapeutics Inc. will present at the 28th Annual JP Morgan Global Healthcare Conference at 4:00 p.m. Pacific Time on Monday, January 11, 2010, to be held at the Westin St. Francis in San Francisco, California.

InteKrin Therapeutics’ President and CEO Denny Lanfear will present at the conference.

 

About InteKrin (www.InteKrin.com)

InteKrin Therapeutics is a privately-held clinical stage biopharmaceutical company focused on the development and commercialization of novel drugs for the treatment of diabetes, obesity and metabolic disease. The Company’s lead program, INT131, is entering Phase 3 clinical trials for treatment of Type 2 diabetes mellitus (T2DM). This product is a highly potent, non-TZD, selective peroxisome proliferator-activated receptor gamma modulator (SPPARM).

Coming after the first generation TZD full PPAR agonists Actos® (pioglitazone) and Avandia® (rosiglitazone), INT131 is the result of an extensive molecular design effort to overcome the chronic safety problems of bone fracture and CHF risk (represented by fluid retention and edema), while minimizing weight gain and retaining efficacy.

INT131 is a unique, next-generation insulin sensitizer that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of type 2 diabetes. Treating and improving insulin sensitivity in diabetic patients by activating PPAR-gamma is an important therapeutic tool for physicians, providing powerful glucose control and durability of effect. As a SPPARM, INT131 selectively modulates PPAR-gamma, and is ideally positioned to safely reduce insulin resistance, addressing an important unmet medical need. This superior safety profile was demonstrated in a robust Phase 2b clinical study of 366 patients, positioning INT131 as the best in class drug in a $6+ Billion global market.


To learn more about InteKrin, visit www.InteKrin.com.


Contact:
Alison Wong
InteKrin Therapeutics Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics Inc


September 30, 2009
InteKrin Therapeutics Presents Positive INT131 Phase 2b Results at the 45th Annual European Association for the Study of Diabetes Meeting

Superior Side Effect Profile with Comparable Efficacy Relative to Actos® Demonstrated

Los Altos, California—Wednesday, September 30, 2009—InteKrin Therapeutics Inc. announced today positive results for INT131 in a 24 week Phase 2b study at the 45th European Association for the Study of Diabetes Meeting in Vienna, Austria. An overview of the data will be presented at 1:45 PM Friday, October 2, 2009 by InteKrin Therapeutics’ Chief Medical Officer, Alex DePaoli, MD. His presentation is entitled “Impact of INT131 Besylate, a Selective PPAR-gamma Modulator (SPPARM), on Glycemic Control in Patients with Type 2 Diabetes in a 24-Week Phase 2b Study (INT131-007).” In this study INT131 demonstrated a superior side effect profile with comparable efficacy when tested side-by-side against 45 mgs daily pioglitazone (Actos®).

“INT131 provided potent glucose lowering with minimal body weight gain, hematocrit reduction, or evidence of edema at 1 mg, replicating the results of the earlier 4-week Phase 2a study,” said Dr. DePaoli. “These data validate the activity of INT131 as a potent selective PPAR-gamma modulator (SPPARM) with significant glucose lowering properties and without the edema or degree of body weight gain seen with pioglitazone.” There was no difference in incidence or severity of edema in any INT131 dose group compared to placebo, while the expected increase in frequency and severity of edema was observed in the pioglitazone group.

“These data confirm INT131 to be an advance for patients who suffer with this disease,” noted Denny Lanfear, InteKrin President and Chief Executive Officer. “As diabetes has become an epidemic throughout the world, physicians desperately need a safe insulin sensitizer in their diabetes therapeutic armamentarium that does not have the safety and tolerability shortcomings of the existing therapies.”

INT131 is a next-generation insulin sensitizer that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of type 2 diabetes. INT131 has been designed to provide a safer therapeutic tool for physicians and patients, which is complementary to available classes of medications, and allows for powerful glucose control and the opportunity for modification of the underlying disease. As a SPPARM, INT131 selectively modulates PPAR-gamma, and is ideally positioned to safely improve insulin resistance, addressing an important unmet medical need.

 

About InteKrin (www.InteKrin.com)

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.


Contact:
Heather Zimmerman
InteKrin Therapeutics Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics Inc


September 30, 2009
InteKrin Therapeutics Presents Positive Long Term INT131 Preclinical Cardiovascular Safety Data at the 45th Annual European Association for the Study of Diabetes Meeting

2-Year Rodent Studies Also Show No Evidence of Carcinogenicity

Los Altos, California—Wednesday, September 30, 2009—InteKrin Therapeutics Inc. announced today positive results for INT131 in long term, high exposure preclinical safety studies. Data will be presented at the 45th Annual European Association for the Study of Diabetes Meeting in Vienna, Austria at 12:45 PM Thursday, October 1, 2009 by InteKrin Therapeutics’ Chief Operating Officer, Linda Higgins, PhD, in a presentation “Chronic Cardiovascular Safety of INT131 Besylate, a Selective PPAR-gamma Modulator (SPPARM) in Rodents and Monkeys is Differentiated from TZD Full Agonists.”

“Typical cardiovascular effects noted with PPAR-gamma full agonists in preclinical and clinical studies, such as weight gain, fluid retention, cardiac hypertrophy, and premature death were not observed in the 2-year studies in rats and mice, or in a 1-year study in cynomolgus monkeys even at the highest doses tested, which provided very high exposure multiples of the clinical exposure at efficacious doses,” said Dr. Higgins. “Results are consistent with in vitro and in vivo studies and with clinical data demonstrating a SPPARM profile of INT131 having unique PPAR-gamma activating properties with minimal cardiovascular side effects.”

“Chronic nonclinical safety studies of PPAR-gamma ligands have been highly predictive of clinical experience,” noted Jeri El Hage, PhD, an expert in PPAR toxicology who served over 18 years in the Center for Drug Evaluation and Research (CDER) at the FDA. “INT131 displayed an unprecedented preclinical safety profile with no cardiac safety signals at exposure multiples far greater than other PPAR agonists tested to date.”

The high cardiovascular safety margin validates the design of INT131 to minimize the safety and tolerability issues associated with full agonist PPAR-gamma agents while retaining the clinically proved anti-diabetic properties of PPAR-gamma. In addition, the 2-year rodent studies showed no evidence of carcinogenicity following lifetime exposure to INT131. These results are enabling for INT131 to initiate planned Phase 3 clinical studies.

INT131 is a next-generation insulin sensitizer that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of type 2 diabetes. INT131 has been designed to provide a safer therapeutic tool for physicians and patients, which is complementary to available classes of medications, and allows for powerful glucose control and the opportunity for modification of the underlying disease. As a SPPARM, INT131 selectively modulates PPAR-gamma, and is ideally positioned to safely improve insulin resistance, addressing an important unmet medical need.

 

About InteKrin (www.InteKrin.com)

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.


Contact:
Heather Zimmerman
InteKrin Therapeutics Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics Inc


September 14, 2009
InteKrin Therapeutics Appoints Linda Slanec Higgins, PhD Chief Operating Officer

Los Altos, California—Monday, September 14, 2009—InteKrin Therapeutics Inc. announced today that Linda Slanec Higgins, PhD has been named Chief Operating Officer. Since late 2007, Dr. Higgins has served as InteKrin’s Chief Scientific Officer after joining the Company earlier that year. Over the past two years, Dr. Higgins has had increasingly broad operational and strategic responsibility in key areas including CMC and dosage form development, Regulatory Affairs, Corporate Development and Product Development.

“Linda’s contributions to InteKrin’s progress have been extraordinarily impactful and decisive,” said Denny Lanfear, InteKrin Chief Executive. “By large measure, her leadership and capabilities have allowed us to move INT131 forward in many dimensions over the past two plus years and successfully surmount the considerable challenges confronting privately funded development stage companies.”

“I am very pleased to have contributed to the advancement of this important therapeutic,” said Dr. Higgins. “We at InteKrin look forward to completing our Phase 2b efforts and moving on into Phase 3.”

 

About INT131

INT131 is a next-generation insulin sensitizer currently in Phase 2b testing that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of type 2 diabetes. Treating and improving insulin sensitivity in diabetic patients by activating PPAR-gamma is an important therapeutic tool for physicians, providing powerful glucose control and durability of effect. As a SPPARM, INT131 selectively modulates PPAR-gamma, thereby enabling the separation of PPAR gamma anti-diabetic efficacy from the well recognized TZD side effects.

 

About InteKrin (www.InteKrin.com)

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.


Contact:
Heather Zimmerman
InteKrin Therapeutics Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics Inc


July 13, 2009
InteKrin Therapeutics Announces Appointment of Geoffrey M. Parker as Chief Business Officer

Los Altos, California—Monday, July 13, 2009—InteKrin Therapeutics Inc. announced today that Geoffrey M. Parker has joined InteKrin as Chief Business Officer. Most recently, Mr. Parker served as a Managing Director and Partner in the Investment Banking Division of Goldman, Sachs & Co. Over the past ten years, Mr. Parker led Goldman Sachs' West Region Healthcare Investment Banking practice during which time he advised many of the biotechnology industry's leading companies.

“We are very pleased to have such an eminent healthcare business professional join us,” said Denny Lanfear, InteKrin Chief Executive. “The expertise, insights and depth of business experience Geoff brings are complementary to the InteKrin team’s capabilities as world class drug developers and scientists.” “InteKrin is an exciting opportunity and INT131 presents significant promise for patient benefit,” said Geoff.

“INT131 has the potential to be a breakthrough product, and I am delighted to be part of the InteKrin team as we complete our Phase 2 work and plan to advance into Phase 3."

 

About INT131

INT131 is a next-generation insulin sensitizer currently in Phase 2b testing that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of type 2 diabetes. Treating and improving insulin sensitivity in diabetic patients by activating PPAR-gamma is an important therapeutic tool for physicians, providing powerful glucose control and durability of effect. As a SPPARM, INT131 selectively modulates PPAR-gamma, thereby enabling the separation of PPAR gamma anti-diabetic efficacy from the well recognized TZD side effects.

 

About InteKrin (www.InteKrin.com)

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.


Contact:
Alison Wong
InteKrin Therapeutics Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics Inc


June 10, 2009
InteKrin Therapeutics Announces INT131 Phase 2a Results at the 2009 American Diabetes Association Annual Meeting

Los Altos, California—Wednesday, June 10, 2009—InteKrin Therapeutics Inc presented Phase 2a clinical study results at the American Diabetes Association annual meeting in New Orleans demonstrating that once a day oral treatment with INT131 provides anti-diabetic efficacy consistent with maximal dose thiazolidinedione (TZD) therapy but with less hematocrit reduction and weight gain.

The 4 week double blind placebo controlled study of INT131 in Type 2 Diabetes Mellitus (T2DM) patients previously not on pharmacological therapy showed a dose dependent decrease in fasting plasma glucose (FPG) at 4 weeks, the primary endpoint of the study. This decrease was already statistically significant at 1 week for both low and high doses (1 mg and 10 mg) of INT131.

The efficacy measured at 4 weeks of 1 mg of INT131 treatment was comparable to the efficacy modeled for this patient population treated with the maximal approved doses of the Actos® and Avandia®, but in contrast the low dose INT131 group did not show the significant weight gain or fluid retention (measured by hematocrit drop) modeled for maximal dose TZDs. The high dose INT131 group showed about twice the decrease in FPG attained with low dose INT131, and a correspondingly greater efficacy compared to that modeled for maximal dose TZDs. Importantly, this greater efficacy was achieved with INT131 without greater weight gain or hematocrit drop than expected for maximal dose TZDs. INT131 was well tolerated in this study with no safety issues noted.

“These data are supportive of INT131 acting as a selective modulator of PPARgamma in T2DM patients,” remarked Dr Alex DePaoli, Chief Medical Officer of InteKrin Therapeutics, who presented the data. “The key observation from this study is that INT131 is a potent insulin sensitizer that lowers fasting glucose as well as the maximal dose of the TZDs while mitigating the typical side effect profile.”

“Translation of the nonclinical profile of INT131 into the clinic is an exciting validation of the selective PPAR modulator design of the molecule,” added Dr Linda Higgins, Chief Scientific Officer of InteKrin Therapeutics. “INT131 retains or exceeds TZD potency and efficacy for glycemic lowering in rodent models of T2DM, while also showing remarkable safety in nonclinical studies of INT131 even at multiples of clinical exposures that far exceed those at which toxicities are observed with TZDs.”

These Phase 2a study data provided the rationale for a double blind placebo controlled 24 week Phase 2b study of 4 doses of INT131 and 45 mg Actos® as active comparator in 360 T2DM patients. InteKrin completed enrollment of the study in March, 2009.

 

About INT131

INT131 is a next-generation, non-TZD insulin sensitizer and selective modulator of PPARgamma (SPPARM). INT131 belongs to a unique, non-TZD chemical class, and was purposely designed to retain the well validated and robust insulin sensitizing efficacy of PPARgamma while minimizing the typical side effects seen with the full agonists TZDs Actos ® and Avandia®. PPARgamma activation treats insulin resistance, a key etiological feature in the onset and subsequent progression of type 2 diabetes.

 

About InteKrin (www.InteKrin.com)

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.


Contact:
Alison Wong
InteKrin Therapeutics Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics Inc


May 28, 2009
InteKrin Therapeutics to Present at the 2009 American Diabetes Association Annual Meeting

Los Altos, California — (PR Newswire)— May 28, 2009  —InteKrin Therapeutics Inc announced today it will present Phase 2a clinical data for INT131, a Selective PPAR Modulator (SPPARM), at the American Diabetes Association annual meeting in New Orleans Saturday, June 6, 2009 during the “Novel Diabetes Therapies in Development in Humans” session at 4:00 pm CDT.

Dr. Alex DePaoli, Chief Medical Officer of InteKrin Therapeutics, will provide a summary of the latest clinical data supporting the design of INT131 to safely and effectively address insulin resistance in a presentation entitled “INT131: Significantly Lowers Glucose Without Typical Thiazolidinedione (TZD) Side Effects in Patients with Type 2 Diabetes”.

 

About INT131

INT131 is a next-generation insulin sensitizer currently in Phase 2b testing that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of type 2 diabetes. Purposefully designed as a SPPARM, INT131 selectively modulates PPAR-gamma, thereby allowing the retention of the clinically proven anti-diabetic efficacy of PPAR gamma activation, while mitigating or eliminating the well recognized side effects of TZD full PPAR gamma agonists rosiglitazone and pioglitazone (Avandia® and Actos® respectively).

About InteKrin (www.InteKrin.com)

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders

Contact:
Alison Wong
InteKrin Therapeutics, Inc.
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics, Inc.

 

March 11, 2009
InteKrin Therapeutics Announces Enrollment Completion of 360 Patient, 24 week Phase 2b Study

Los Altos, California — (PR Newswire)— March 11, 2009  InteKrin Therapeutics, Inc., a clinical stage biopharmaceutical company focused on diabetes, metabolism and obesity, today announced it has completed enrollment of a 360 patient Phase 2b study of INT131, a novel, non-TZD selective modulator of PPAR gamma (SPPARM) for the treatment of Type 2 diabetes (T2DM). INT131-007 is a 24 week, high dose active comparator (45mg Actos®) and placebo controlled study of INT131 at four doses in poorly controlled Type 2 diabetics.

“INT131-007 is an important study designed specifically to extend the encouraging findings from our Phase 2a study and demonstrate the unique properties of INT131, a potent insulin sensitizer, in patients with inadequately controlled type 2 diabetes mellitus (T2DM), said Alex DePaoli, M.D. InteKrin’s Chief Medical Officer. “This Phase 2b study will provide critical efficacy, safety, and tolerability data to allow differentiation of INT131 from Actos® and inform dose selection for the Phase 3 program”. “InteKrin is very pleased to achieve this critical development milestone for INT131,” remarked InteKrin's President and CEO, Denny Lanfear. “We anticipate having results from INT131-007 in the second half of this year concurrent with completion of all nonclinical and CMC efforts, enabling initiation of the INT131 Phase 3 program in 1H2010.”

INT131 is a selective PPAR gamma modulator which has consistently demonstrated the separation of the powerful PPAR gamma anti-diabetic efficacy from the well recognized TZD side effects. INT131 is well positioned to fulfill the unmet medical need for patients requiring safe treatment of insulin resistance, a key etiological feature in the onset and subsequent progression of T2DM, which remains inadequately addressed by current therapies.

About InteKrin (www.InteKrin.com):

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.

To learn more about InteKrin, visit www.InteKrin.com.

Contact:
Alison Wong
InteKrin Therapeutics, Inc.
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics, Inc.

 

January 8, 2009
InteKrin Therapeutics to Present at the 27th Annual JP Morgan Healthcare Conference on Tuesday, January 13, 2009

Los Altos, California--(PR Newswire)Thursday, January 8, 2009—InteKrin Therapeutics, Inc., will present at the 27th Annual JP Morgan Global Healthcare Conference at 9:00 a.m. Pacific Time on Tuesday, January 13, 2009, to be held at the Westin St. Francis in San Francisco, California. InteKrin Therapeutics’ President and CEO Denny Lanfear will present at the conference. 

About InteKrin (www.InteKrin.com):

InteKrin Therapeutics is a privately-held clinical stage biopharmaceutical company focused on the development and commercialization of novel drugs for the treatment of diabetes, obesity and metabolic disease. The company’s lead program is INT131, a late-stage non-TZD SPPARM (Selective Peroxisome Proliferator-Activated Receptor Modulator). INT131 is the result of an extensive molecular design effort to address the problematic safety concerns of TZD full PPAR agonists Actos® (pioglitazone) and Avandia® (rosiglitazone), which while efficacious are associated with weight gain, edema, congestive heart failure and bone fracture. Unlike TZDs, INT131 was specifically selected for its ability to separate powerful PPAR anti-diabetic efficacy from these serious TZD side effects. 

INT131 is a next-generation insulin sensitizer that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of type 2 diabetes. Treating and improving insulin sensitivity in diabetic patients by activating PPAR-gamma is an important therapeutic tool for physicians, providing powerful glucose control and durability of effect. As a SPPARM, INT131 selectively modulates PPAR-gamma, and is ideally positioned to safely reduce insulin resistance, addressing an important unmet medical need. 

InteKrin expects to complete enrollment of its 360 patient, 24-week, placebo-controlled Phase 2b study of INT131 at four doses compared to 45mg Actos in Q1 09 and to have final results later this year.

To learn more about InteKrin, visit www.InteKrin.com.

Contact:   
Alison Wong
InteKrin Therapeutics, Inc.  
4300 El Camino Real, Suite 201 
Los Altos, CA 94022 
1-650-941-5501  

SOURCE: InteKrin Therapeutics, Inc.



August 4, 2008
InteKrin Therapeutics Announces $20 Million Series C Financing

Los Altos, California--(PR Newswire)—Monday August 4, 2008
InteKrin Therapeutics, Inc., a clinical stage biopharmaceutical company focused on the development of products for diabetes, metabolism and obesity today announced it has completed the first close of a Series C venture financing for $18.25 million. The financing was led by Skyline Ventures of Palo Alto, CA and Managing Director David Lowe Ph.D. of Skyline will join InteKrin’s Board of Directors. Existing major investors Sofinnova Ventures and OrbiMed Advisors also significantly participated, as did other earlier investors. The Company anticipates a second close of the Series C bringing the total for the round to $20 million to support the continued development of INT131, a non- TZD selective modulator of PPAR gamma (SPPARM) for treatment of Type II diabetes (T2DM).

"InteKrin is very pleased to have Skyline, a premier health care venture firm, lead its Series C financing," remarked InteKrin's President and CEO Denny Lanfear. "This investment and the ongoing support of our existing investors including Sofinnova and OrbiMed will allow us to fully prepare INT131 for the initiation of the Phase 3 studies in 1H10 and maintain our rapid development pace."

"The nonclinical safety multiples seen with INT131 together with the strong efficacy seen in the Phase 2a study present a unique profile", commented Skyline Ventures’ David Lowe Ph.D. "The biology of INT131 and its demonstrated ability to selectively modulate PPAR gamma promises to deliver to patients glucose lowering efficacy without the safety compromises of currently available insulin sensitizers.”

INT131 was designed specifically to antagonize characteristic TZD adverse effects while retaining powerful PPAR gamma anti-diabetic efficacy, and represents a new product and chemical class. INT131 is well positioned to fulfill the unmet medical need for a safe treatment of insulin resistance, the key etiological feature in the onset and subsequent progression of T2DM and metabolic syndrome.

Phase 2a clinical efficacy data was presented in June 2008 at ADA and new nonclinical safety data will be presented next month at EASD. InteKrin’s previously announced 360 patient, 24 week placebo controlled Phase 2b study with a 45mg Actos® comparator arm was initiated in February, 2008 and results are expected to be completed in 2H09.

About InteKrin (www.InteKrin.com):

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.

To learn more about InteKrin, visit www.InteKrin.com.

Contact:
Alison Wong
InteKrin Therapeutics, Inc.
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics, Inc.


June 8, 2008  
InteKrin Therapeutics Presents Phase 2a Data at American Diabetes Association Meeting for INT131, a non-TZD SPPARM

InteKrin Therapeutics, Inc., a privately-held clinical stage biopharmaceutical company focused on the development and commercialization of novel drugs for the treatment of diabetes, obesity and metabolic disease, presented data from a Phase 2a study with INT131, a non-TZD Selective Peroxisome Proliferator-Activated Receptor Modulator (SPPARM), in patients with Type 2 diabetes mellitus (T2DM) at the American Diabetes Association 68th Scientific Sessions held in San Francisco, California. PDFDownload Poster

In a placebo controlled, double-blind, four week Phase 2a study, INT131 administration demonstrated a significant improvement in fasting plasma glucose compared to baseline and placebo at doses of 1 mg and 10 mg daily, in subjects with T2DM on no drug therapy. The changes in FPG were accompanied by significant improvements in insulin resistance and an increase in adiponectin, a key biomarker of PPARγ mediated efficacy.    INT131 was safe and well tolerated, without evidence of the recognized side effects of the full agonist TZDs at a dose that provides glycemic improvement as good as or better than the highest approved doses of Actos® and Avandia®.  

“INT131 has consistently demonstrated potent and selective PPARγ modulation through each phase of development and, this clinical data is an important step in that continued progression.  This Phase 2a data demonstrate that it may be possible to achieve significant glucose lowering without recognized TZD adverse effects, such as edema and weight gain, which is a genuine breakthrough for this target.” said Alex DePaoli, M.D. InteKrin’s Chief Medical Officer.

INT131 was selected specifically for its ability to antagonize characteristic TZD adverse effects while retaining powerful PPARγ anti-diabetic efficacy, and represents a new product and chemical class.  INT131 is well positioned to fulfill the unmet medical need for patients requiring safe treatment of insulin resistance, a key etiological feature in the onset and subsequent progression of T2DM, which remains inadequately addressed by current therapies. 

InteKrin has initiated a 360 patient, 24 week placebo controlled Phase 2b study with a 45mg Actos comparator arm in February, 2008 and expects results to be completed in 2009.

About InteKrin (www.InteKrin.com):
InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.  
To learn more about InteKrin, visit www.InteKrin.com.

Contact:  
Alison Wong
InteKrin Therapeutics, Inc.
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

 SOURCE: InteKrin Therapeutics, Inc.


February 25, 2008
InteKrin Therapeutics Announces Initiation of Phase 2b Study in Type 2 Diabetes with INT131 

Los Altos, California--(PR Newswire)—February 25, 2008—InteKrin Therapeutics, Inc., a privately-held clinical stage biopharmaceutical company focused on the development and commercialization of novel drugs for the treatment of diabetes, obesity and metabolic disease, announced today that it has initiated a Phase 2b study in diabetic patients with its lead product candidate INT131, a non-TZD SPPARM (Selective Peroxisome Proliferator-Activated Receptor Modulator). INT131 was the result of an extensive molecular design effort to address the product profile deficiencies of current TZD therapy, which while efficacious present problematic safety concerns. INT131 was selected specifically for its ability to reduce characteristic TZD adverse effects while retaining powerful PPAR anti-diabetic efficacy.  This placebo controlled, double-blind, Phase 2b study includes multiple doses of orally administered INT131 once daily, and Actos® (pioglitazone) as an active comparator.

“INT131 has consistently demonstrated potent and selective PPAR-gamma modulation through each phase of development including recently completed primate safety studies, wherein an absence of recognized TZD adverse effects such as edema offers a genuine breakthrough for this target.” said Linda Slanec Higgins, PhD, InteKrin’s Chief Scientific Officer. “Preclinical safety multiples with INT131 are far greater than those seen with the currently marketed, first generation TZD full agonists.” 

“From a clinical perspective, insulin resistance is a key etiological feature in the onset and subsequent progression of Type 2 Diabetes, and it remains inadequately addressed by current therapies. INT131 has been demonstrated to be a potent and efficacious insulin sensitizer in humans and offers the opportunity for disease modification without the edema and weight gain of current TZD therapies” said Alex DePaoli, MD, InteKrin’s Chief Medical Officer. “The initiation of this robust Phase 2b study represents an important milestone in bringing a novel, breakthrough therapeutic to patients which is complementary to other treatment modalities.” 

“There is a significant product profile gap in treating and improving insulin sensitivity in diabetic patients as a result of safety deficiencies with existing TZD therapy. INT131 is ideally positioned to potentially fulfill an unmet medical need for patients” said Denny Lanfear, InteKrin’s President and CEO. “This study represents an important step in our overall global product development plan.” 

About InteKrin (www.InteKrin.com):

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes, obesity and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages. InteKrin's team of world-class scientific and medical experts includes veterans from several successful BioPharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders.  

To learn more about InteKrin, visit www.InteKrin.com.

 

Contact:  
Alison Wong
InteKrin Therapeutics, Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

 SOURCE: InteKrin Therapeutics, Inc.



November 8, 2007
InteKrin Therapeutics, Inc. Appoints Former Amgen Clinical Development Executive Chief Medical Officer

Los Altos--(BUSINESS WIRE)—November 8, 2007—InteKrin Therapeutics, Inc., a privately-held clinical stage biopharmaceutical company focused on the development and commercialization of novel drugs for the treatment of diabetes and cardio-metabolic diseases, announced today that Alex M. DePaoli M.D. has joined the company as Chief Medical Officer. Dr. DePaoli will be a member of InteKrin’s senior management team and will be responsible for the clinical development of the Company’s pipeline of products.

“We are extremely pleased to have a seasoned world-class drug developer of Alex’s caliber join the company” said Denny Lanfear, InteKrin Chief Executive. “Alex joins us as we prepare to initiate the Phase IIb study for our lead compound INT131, a non-TZD selective PPAR-gamma modulator (SPPARM) licensed from Amgen earlier this year. While at Amgen, Alex was broadly responsible for the metabolic and endocrine therapeutic area and has been closely involved with multiple novel treatment strategies. His decision to join InteKrin and direct INT131’s further development is a strong endorsement of his confidence in its therapeutic potential. The addition of such a highly regarded drug developer and clinician to the team is very positive for the Company.” 

“I am thrilled to be joining the team at InteKrin and to have the opportunity to advance INT131 into Phase IIb in early 2008” said Dr. DePaoli. “This moiety is the result of a 10-year comprehensive scientific program at Tularik and Amgen resulting in what could be a significant clinical advancement in the treatment of Type 2 Diabetes. Insulin resistance is the key etiological feature to the onset and subsequent progression of the disease and as a true SPPARM, INT131 promises insulin sensitization benefits without the edema, fluid retention and weight gain exhibited by the TZDs.” 

Dr. DePaoli joins InteKrin after more than 16 years of experience in the diabetes and obesity field. He trained in Clinical and Molecular Endocrinology at the University of Chicago with Drs. Kenneth Polonski and Graham Bell. His clinical and research interests in diabetes and obesity were focused during his work at the Sansum Diabetes Research Institute which led him to join Amgen to build the Metabolic Disease Area and direct the Leptin program. At Amgen he also directed the development of a broad array of metabolic disease targets focused on translating novel pathways into the clinic. These pathways include 11 Beta HSD-1, RANK Ligand, calcium sensing receptor, PPAR-gamma modulation, and MCH-R1. He also maintains his clinical practice. 

About InteKrin (www.InteKrin.com):

InteKrin Therapeutics is a privately-held clinical-stage drug development company focused on diabetes and metabolic disease. InteKrin’s business strategy is to build a robust portfolio of high value products by in-licensing clinical-stage therapeutic candidates that address significant unmet medical needs and rapidly move them through critical development stages under the direction of InteKrin’s accomplished management team and world-class SAB. The company was co-founded by Chief Executive Denny Lanfear, a former Amgen VP and Officer, and by Scientific Advisory Board Chair Christos Mantzoros, M.D., D.Sc., a leading clinical endocrinologist and Associate Professor at Harvard Medical School. InteKrin's team of world-class scientific and medical experts includes veterans from several successful biopharma organizations, internationally recognized experts in nuclear receptors and metabolism, top scientists formerly with the Food and Drug Administration and key clinical and commercialization leaders who brought earlier PPAR agonists to market.  

InteKrin’s lead therapeutic candidate, INT131, is a potent non-TZD SPPARM (Selective Peroxisome Proliferator-Activated Receptor Modulator) that was specifically engineered to have equal or better efficacy to the currently marketed TZDs without weight gain and edema side effects. INT131 has successfully completed Phase IIa clinical trials for diabetes and Phase IIb trials will be initiated in Q108.  

To learn more about InteKrin, visit www.InteKrin.com.

 

Contact:  
Alison Wong
InteKrin Therapeutics, Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501



May 21, 2007
InteKrin Therapeutics announces appointment of Linda Slanec Higgins PH.D. as Vice President Preclinical Research and Development

Los Altos‚ CA – May 21‚ 2007   – InteKrin Therapeutics, Inc., a clinical stage biopharmaceutical company focused on the development of products for diabetes, metabolism and obesity today announced the appointment of Linda Slanec Higgins, Ph.D. to the position of Vice President, PreClinical Research and Development. Dr. Higgins will be a member of InteKrin’s senior management team and will be responsible for the biology and early stage development of the Company’s pipeline products.

“We are extremely pleased to have a scientist of Linda’s caliber responsible for the biology of INT131 and our other product candidates” said Denny Lanfear, Founder and Chief Executive. “Her breadth of experience, expansive intellect and impressive track record qualify her well to assume InteKrin’s senior scientific leadership position. Our standards are extremely high, and I am confident Linda will be an excellent fit with her peers on our Scientific Advisory Board.”

“I am very pleased to be joining the team at InteKrin Therapeutics in the development of INT131” said Dr. Higgins. “This is a truly novel selective PPAR modulator, resulting from an extraordinary discovery and development effort. There is a continuum of consistent data from the molecular biology to the clinical experience which demonstrates high therapeutic potency without the undesirable activities of the marketed full agonists. Its biology thus holds great potential to help a large and growing patient population. This is a rare opportunity to participate in the development of a very promising therapeutic moiety.”

Dr. Higgins joins InteKrin after more than 15 years of experience in the pharmaceutical industry. Previously she was with Scios, Inc. where she was most recently Head of Research holding responsibility for drug discovery, preclinical development, and translational medicine. She has led multiple teams for programs in discovery through early clinical development focused on CNS, inflammatory, oncology, cardiovascular, hematology and fibrotic disorders which were advanced internally as well as in partnership with major pharmaceutical companies. During her tenure at Scios, it grew from a discovery organization, to a fully integrated biopharmaceutical company marketing a product discovered in house, to an operating company owned by Johnson & Johnson. Dr. Higgins has authored over 50 original peer reviewed scientific papers and invited reviews, and is inventor on over a dozen patents. She earned an AB in Behavioral Physiology with High Honors and Distinction from Kenyon College, Gambier Ohio; a PhD in Neurosciences from the University of California, San Diego School of Medicine; and postdoctoral training in Molecular Genetics at the Howard Hughes Medical Institute at the University of California, Berkeley.

 

About InteKrin

InteKrin Therapeutics, Inc. is a privately-held clinical stage biopharmaceutical company based in Los Altos, California developing therapeutics for diabetes, obesity and metabolic disorders. The company was founded in 2005 by Denny Lanfear, a former Vice President and Officer of Amgen, and clinical endocrinologist Christos Mantzoros, M.D., DSc, FACP, FACE, Associate Professor of Medicine at Harvard Medical School. InteKrin's Scientific Advisory Board includes veterans from several successful biopharma organizations, internationally recognized experts in nuclear receptors and metabolism as well as top scientists formerly with the Food and Drug Administration. Its lead product, INT131, is a novel SPPARM (Selective Peroxisome Proliferator-Activated Receptor Modulator) which is in Phase II clinical trials for diabetes. The company focuses on high value therapeutics in addressing unmet medical needs. To learn more about InteKrin, visit www.intekrin.com

 

Contact:
Alison Wong, InteKrin Therapeutics, Inc




January 11, 2007
InteKrin Therapeutics Secures $23 M Venture Financing
Company Will Focus on the Areas of Diabetes, Metabolism and Obesity

PALO ALTO, Calif. – January 11, 2007    InteKrin Therapeutics, Inc., a clinical stage biopharmaceutical company focused on the development of products for diabetes, metabolism and obesity today announced it had secured $23 million in venture financing. The financing was led by Sofinnova Ventures and included Orbimed Advisors and Vivo Ventures, as well as earlier investors Asset Management and Sears Capital Management. The round will fund the clinical development of InteKrin's lead drug candidate, INT131, targeting type II diabetes.

"InteKrin is very pleased to have the financial support and confidence of these excellent health care investors," remarked InteKrin's President and CEO Denny Lanfear. "This investment by Sofinnova and OrbiMed will allow InteKrin to pursue the development of INT131 through Phase IIb clinical trials while building the company's portfolio of important diabetes and metabolism therapeutics."

"InteKrin has a proven business strategy to in-license high potential clinical stage products from large biotech and pharmaceutical, then carry them through to critical clinical stages," commented Sofinnova General Partner Jim Healy, M.D., Ph.D. "The investors have confidence in the company's product development team and scientific advisory board, which are world class. They're a formidable group who can carry INT131 through the phases of development necessary for this therapeutic to reach needy patients."

Taking seats on InteKrin's board of directors are investors Healy, Sam Wertheimer, Ph.D. of Orbimed, and Barry Selick, Ph.D., CEO of Threshold Pharmaceuticals. They join InteKrin's Chairman Lowell Sears and Paul Truex, CEO of Anthera Pharmaceuticals, on InteKrin's Board.

About InteKrin

InteKrin Therapeutics, Inc. is a privately-held clinical stage biopharmaceutical company based in Palo Alto, California developing therapeutics for diabetes, obesity and metabolic disorders. The company was founded in 2005 by Denny Lanfear, a former Vice President and Officer of Amgen, and Christos Mantzoros, M.D., DSc, renowned clinical endocrinologist and Associate Professor of Medicine at Harvard Medical School. InteKrin's Scientific Advisory Board includes veterans from several successful biopharma organizations, internationally recognized experts in nuclear receptors and metabolism as well as top scientists formerly with the Food and Drug Administration. The company focuses on high value therapeutics in addressing unmet medical needs. To learn more about InteKrin, visit www.intekrin.com


Contact:
Alison Wong, InteKrin Therapeutics, Inc




January 10, 2007
InteKrin Therapeutics Licenses Diabetes Product
Novel Phase II Insulin Sensitizer

PALO ALTO, Calif. – January 10, 2007 -- InteKrin Therapeutics, Inc., a privately held clinical stage biopharmaceutical company focused on the development of products for diabetes, metabolism and obesity, announced today that it has entered into a license agreement with Amgen Inc. under which InteKrin has obtained worldwide development and commercialization rights to Amgen’s PPAR gamma selective modulator and partial agonist, INT131. Formerly known as AMG131 and first developed by Tularik, Inc., this compound utilizes a well-validated and potent target for the treatment of diabetes and insulin resistance.

“We are very excited to pursue the further development of this promising compound for Type II diabetes. INT131 was specifically designed to dial-out side effects while still delivering high efficacy” remarked InteKrin’s President and CEO Denny Lanfear. “This molecule is a good example of the type of scientifically superior compound InteKrin will be focused on as it further develops its portfolio.”

“Based on the clinical data generated to date, we believe INT131 has the potential to become a highly effective therapeutic for the treatment of Type 2 diabetes, without the weight gain and edema seen with existing therapies.” commented InteKrin Co-Founder Christos Mantzoros, M.D., DSc, of Harvard Medical School, “We are looking forward to completing the clinical development program and getting this important product to patients. We expect that its therapeutic profile may also be useful in pre-diabetes, helping patients delay the onset of the disease.”

According to a June 2005 analyst report by Merrill Lynch, about 40 million people in the United States have pre-diabetes. An additional 18 million people in the U.S. currently have Type II diabetes, with 1.3 million new diagnoses each year. Morgan Stanley corroborates the magnitude of diabetes, predicting a drug market of $35 billion by 2012, up from $17 billion in 2005.

About InteKrin
InteKrin Therapeutics, Inc. is a privately-held clinical stage biopharmaceutical company based in Palo Alto, California developing therapeutics for diabetes, obesity and metabolic disorders. The company was founded in 2005 by Denny Lanfear, former Amgen Vice President and Officer, and Christos Mantzoros, M.D., DSc, renowned clinical endocrinologist and Associate Professor of Medicine at Harvard Medical School. InteKrin’s Scientific Advisory Board includes veterans from several successful biopharmaceutical organizations, internationally recognized experts in nuclear receptors and metabolism as well as top scientists formerly with the Food and Drug Administration. The company focuses on high value therapeutics in addressing unmet medical needs. To learn more about InteKrin, visit www.intekrin.com.

Contact:
Alison Wong, InteKrin Therapeutics, Inc