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:
Eric Easom
Sr. Director, Business Development and Marketing
InteKrin Therapeutics, Inc.
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

SOURCE: InteKrin Therapeutics, Inc.

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.
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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:  
Eric Easom  
Sr. Director, Business Development and Marketing
InteKrin Therapeutics, Inc.
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

 SOURCE: InteKrin Therapeutics, Inc.

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:  
Eric Easom  
Sr. Director, Business Development and Marketing
InteKrin Therapeutics, Inc
4300 El Camino Real, Suite 201
Los Altos, CA 94022
1-650-941-5501

 SOURCE: InteKrin Therapeutics, Inc.

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:  
Eric Easom  
Sr. Director, Business Development and Marketing

InteKrin Therapeutics, Inc

4300 El Camino Real, Suite 201

Los Altos, CA 94022

1-650-941-5501

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:
Eric Easom, InteKrin Therapeutics, Inc

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:
Eric Easom, InteKrin Therapeutics, Inc

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:
Eric Easom, InteKrin Therapeutics, Inc