InteKrin Therapeutics Announces Initiation Of Phase 2b Study In Type 2 Diabetes With INT131

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 26 Feb 2008 - 0:00 PDT

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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 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(R) (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

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 http://www.InteKrin.com.

InteKrin Therapeutics, Inc.
http://www.InteKrin.com