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Metabolic Solutions’ improves on TZD safety

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Metabolic Solutions Development Company reports preliminary Phase IIa data showing its lead compound, MSDC-0160, improves insulin sensitivity and lowers blood glucose levels in humans without the side effects of current therapies when taken over a 28-day period. The firm says MSDC-0160, a PPAR-sparing thiazolidinedione (TZD) is similar to Lilly's TZD Actos (pioglitazone) in that it lowers circulation of fatty acids and increases HDL cholesterol, but dissimilar from Actos in that is does not decrease the levels of circulating blood cells or cause weight gain. Delivering a similar drug that would avoid the safety concerns with the broad TZDs, including the cardiovascular safety issues with GSK's Avandia (rosiglitazone), could be a significant market opportunity. The company will gather additional safety and expanded efficacy data in a 90-day Phase IIb study planned for late 2009. The firm also plans to submit an IND for a second-generation compound by the end of 2009. MSDC President Jerry Colca participated in the early development of pioglitazone while working at Upjohn

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