MSDC-0160 and MSDC-0602 are the first therapeutic agents in a new class of insulin sensitizers characterized as mTOT Modulators. Unlike current insulin sensitizers, MSDC-0160 and MSDC-0602 do not activate the PPARγ nuclear receptor at therapeutic doses and, as such, do not exhibit the side effect profile associated with current insulin sensitizers.
A 90-day, randomized, double-blind, comparator- and placebo-controlled, multi-dose Phase 2b clinical study in 258 patients with type 2 diabetes was completed in December 2011. Data from this study was presented at the American Diabetes Association 72nd Scientific Sessions in June 2012.
MSDC-0160 also is being studied at Rush University Medical Center (Chicago) in a Phase 2a trial in patients diagnosed with mild Alzheimer’s disease funded by the Alzheimer’s Drug Discovery Foundation. The compound is also being investigated in animal models of polycystic kidney disease in preclinical animal models in collaboration with the Polycystic Kidney Foundation.
A 28-day, randomized, double-blind, comparator- and placebo-controlled, multi-dose Phase 2a study in 129 patients with type 2 diabetes completed in August 2011. This proof-of-concept clinical study showed that MSDC-0602 achieved significant glucose control and increased insulin sensitivity in type 2 diabetes patients. A Phase 2b study is expected to begin Q3 2012.
MSDC-0602 also is being evaluated in animal models of fatty liver disease supported by a grant from the National Institute on Alcohol Abuse and Alcoholism of the National Institutes of Health.
MSDC is utilizing traditional medicinal chemistry to develop new chemical entities (NCEs) that are non-TZD, oral mTOT Modulator insulin sensitizers for the treatment of type 2 diabetes. The company anticipates the first of these NCEs will enter clinical investigation in 2013.