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New Insulin Sensitizer (CRx-401) Improves Control Without Weight Gain

Posted: Thursday, August 23, 2007

CombinatoRx, Incorporated announced that it has dosed the first patient in a Phase 2a proof of concept clinical trial in Type 2 diabetes with CRx-401, a novel insulin sensitizer designed to provide anti-diabetic activity without promoting weight gain.

"CRx-401 was selected for clinical evaluation from a pool of novel synergistic combinations discovered by CombinatoRx based on preclinical data demonstrating decreased fasting glucose and insulin resistance without weight gain," commented Daniel Grau, Chief Operating Officer of CombinatoRx. "CRx-401 offers the potential to achieve and maintain multiple treatment goals including reducing hyperglycemia, reducing elevated triglycerides (TG), and elevating high density cholesterol (HDL), the "good" cholesterol".

CRx-401 is a novel insulin sensitizer designed to provide anti-diabetic activity without promoting weight gain. CRx-401 is a synergistic novel combination containing a sustained-released therapeutic dose of bezafibrate, an anti-cholesterol agent, and a low dose of diflunisal, an analgesic salicylate derivative. A once-daily co-formulated tablet is in development. CRx-401 has the potential to offer a novel anti-diabetic treatment for newly diagnosed and poorly controlled diabetes patients.

This clinical trial is a multi-center, randomized study evaluating the safety and efficacy of CRx-401, as an add-on therapy in Type 2 diabetes, in comparison to bezafibrate alone. Approximately 80 subjects with Type-2 diabetes who are poorly controlled on metformin are planned to be enrolled. Patients will be randomized in a 1:1 ratio to CRx-401 (400mg bezafibrate sustained release and 250mg diflunisal) or 400mg of bezafibrate sustained release plus placebo. Patients will remain on their pre-existing stable dose of statins and low dose aspirin. Endpoints include fasting plasma glucose (FPG), HbA1c, TG, HDL and insulin resistance (HOMA-IR).

Source: Diabetes In Control