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

Posted on: Wednesday, 11 March 2009, 05:00 CDT

LOS ALTOS, Calif., March 11 /PRNewswire/ -- 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(R)) 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(R) 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.

SOURCE InteKrin Therapeutics, Inc.

Source: PR Newswire

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