Metabolic Solutions Development Company Reports Positive Top-Line Results From Phase 2a Study of Its Second Compound to Treat Type 2 Diabetes
KALAMAZOO, Mich., Sept. 8, 2011 /PRNewswire/ -- Metabolic Solutions Development Company, LLC (MSDC) confirmed today the potential of MSDC-0602 to achieve significant glucose control in type 2 diabetes patients and increase insulin sensitivity based on preliminary analysis from its Phase 2a trial of MSDC-0602, a novel insulin sensitizer.
Importantly, given the blood glucose (HbA1c) lowering shown in this short study, these data support the company's expectation of a >1.5 percent reduction in HbA1c potentially without the undesirable weight gain and other PPAR-related side-effects(1). According to the Diabetes Control and Complications Trial, as HbA1c is lowered, the risks of diabetic complications such as eye, nerve and heart disease is significantly reduced.
"This proof-of-concept trial affirmed the potential of this novel insulin sensitizer to lower blood glucose and increase insulin sensitivity without the side-effects found with currently marketed products," said Jerry Colca, Ph.D., president and Chief Scientific Officer of MSDC. "The data are encouraging and we are proceeding to design a Phase 2b study of longer duration."
The safety, tolerability and efficacy of MSDC-0602 were evaluated in a 28-day, randomized, double-blind, comparator- and placebo-controlled, multi-dose study in 129 patients with type 2 diabetes. Patients were randomized to MSDC-0602, 45 mg of pioglitazone or placebo. No safety concerns were uncovered for any treatments and all treatments were well tolerated. 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-0602 is an insulin sensitizer that is selective for a molecular target connecting mitochondrial metabolism to cell functio