InteKrin Therapeutics Presents Positive INT131 Phase 2b Results At The 45th Annual European Association For The Study Of Diabetes Meeting

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials;  Conferences
Article Date: 01 Oct 2009 - 2:00 PDT

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InteKrin Therapeutics Inc. announced 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

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.

Source: InteKrin Therapeutics Inc

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