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Founded in 2006 by former Upjohn Company and Pfizer researchers Jerry Colca, PhD and Rolf Kletzien, PhD, Metabolic Solutions Development Company (MSDC) is developing new therapies to treat metabolic diseases associated with altered mitochondrial function, especially insulin resistance and type 2 diabetes. Driven by its epidemic prevalence, type 2 diabetes has been a rich area of pharmaceutical development. In the 1980s, MSDCs co-founders led a research team at The Upjohn Company focused on the development of the insulin sensitizer, pioglitazone. Since then, many studies have shown that insulin sensitizers restore a patients response to insulin (the bodys regulator of blood glucose levels), which uniquely affects the course of diabetes by attacking underlying insulin resistance and mitochondrial dysfunction. However, well-documented side effects unique to the insulin sensitizers approved to date by the FDA, particularly troglitazone and rosiglitazone, have limited their full use as therapeutic agents for the treatment of type 2 diabetes.
MSDCs founders have used their unique insights to identify a novel molecular target and strategy to develop a new mechanistic class of oral insulin sensitizers that are selective for a previously unidentified mitochondrial target, and that modulate metabolic signaling. These attributes result in improved insulin sensitivity and increased production of brown fat, independent of the activation of nuclear transcription factors. The companys pioneer and lead products, MSDC-0160 and MSDC-0602, are novel insulin sensitizers that selectively modulate mitochondrial control of certain metabolic-signaling and nutrient-sensing pathways, resulting in improved insulin action without fluid retention or weight gain. 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-0602 is currently being studied in a Phase 2a 28-day, randomized, double-blind, comparator- and placebo-controlled clinical trial involving approximately 125 patients with type 2 diabetes at 15 sites throughout the U.S. Data from this Phase 2a study are expected in September 2011. This study follows the completion of two Phase 1 trials in which no safety concerns were observed. Additional safety and expanded efficacy data will be obtained from a Phase 2b study of MSDC-0602 that is targeted to begin in the first quarter of 2012. 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. |
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