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Metabolic Solutions Development Company Reports Positive Top-Line Results From Phase 2a Study of Its Second Compound to Treat Type 2 Diabetes

September 8, 2011 By Bio-Medicine.Org

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

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SOURCE

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