InteKrin Therapeutics Announces Initiation of Phase 2b Study in Type 2 Diabetes w...( LOS ALTOS Calif. Feb. 25 /- InteK...),Health

LOS ALTOS, Calif., Feb. 25 /PRNewswire/ -- 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(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 imp
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