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Summary
Phase II clinical data suggests that MSDC-0160 successfully separates insulin sensitizing activity from the side effects associated with other insulin sensitizers. Since insulin sensitizers remain among the most effective agents for controlling blood glucose and also improve key factors related to insulin sensitivity (such as inflammation, circulating lipids and blood pressure), this candidate offers significant advantages over existing type 2 diabetes treatments. MSDC-0160 is based upon MSDCs understanding of a novel target and metabolic signaling pathways that it believes influence the outcome of the treatments.

Development Status
MSDC-0160 is currently being studied in a Phase 2b 90-day, randomized, double-blind, comparator- and placebo-controlled clinical trial involving approximately 330 patients with type 2 diabetes at 26 sites throughout the U.S. Data from this study are expected in December 2011. In a recently completed Phase 2a study, MSDC‑0160 successfully achieved effective glucose control and improvement in a number of other metabolic parameters, without the fluid retention or weight gain associated with current insulin sensitizers.

MSDC-0160 will be studied in a Phase 2a trial at Rush University Medical Center, Chicago involving patients diagnosed with mild Alzheimers disease funded by the Alzheimers Drug Discovery Foundation.

Completed Trials
Phase 2a
Over 100 patients participated in this double-blind, placebo- and active-controlled, multicenter clinical trial that was conducted in the United States.

MSDC-0160 improved insulin sensitivity, lowered glucose, insulin, triglycerides, and free fatty acids, and significantly increased good (HDL) cholesterol. Unlike Actos®, MSDC-0160 did not decrease the levels of circulating blood cells (evidence of fluid retention) and did not produce an increase in body weight.

Phase 1
MSDC completed two successful Phase 1 trials that showed early indications of an improved pharmacokinetic and safety profile. The compound has a single major metabolite, as in the preclinical species. Both the parent drug and metabolite have a half-life of approximately 12 hours supporting one a day, oral dosing.