InteKrin Therapeutics Presented Phase 2a Data INT131, a non-TZD SPPARM
The results 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) are here.
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 PPAR-gamma 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(R) and Avandia(R).
"INT131 has consistently demonstrated potent and selective PPAR-gamma 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 PPAR-gamma 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.
Presented at the American Diabetes Association 68th Scientific Sessions held in San Francisco, California.
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