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Elcelyx Therapeutics Enrolling Phase 2b Trial of NewMet for Type 2 Diabetes
Date:5/20/2013

SAN DIEGO, May 20, 2013 /PRNewswire/ -- Enrollment of patients with Type 2 diabetes is underway in Elcelyx Therapeutics' Phase 2b dose-finding clinical trial of product candidate NewMet™, a delayed-release formulation of generic metformin, the foundational treatment for Type 2 diabetes. Elcelyx expects to complete enrollment of 240 patients in the multicenter U.S. program in June. Results of the trial's primary endpoint of change in fasting plasma glucose are expected in late summer, and the read-out for long-term glucose lowering and weight benefits is due in the fourth quarter of 2013.

Elcelyx has not changed the way metformin works but instead, has discovered how and where metformin works and has leveraged that understanding to develop an improved product. Elcelyx believes metformin's primary site of action is the lower bowel rather than the circulation. By targeting the lower bowel, NewMet dramatically reduces the amount of active ingredient in the bloodstream while still maintaining metformin's potent glucose lowering benefit. Phase 2a trial results indicate that a significantly lower once-daily dose of NewMet that maintains efficacy may meaningfully reduce metformin's gastrointestinal side effects and eliminate the need for titration to initiate treatment.

"Elcelyx's approach of reducing bioavailability of metformin is quite ingenious and turns on its head the incorrect belief that greater exposure to metformin is needed for superior therapeutic benefit," said Ralph A. DeFronzo, M.D., Professor of Medicine and Chief of the Diabetes Division at the University of Texas Health Science Center and the Audie L. Murphy Memorial Veterans Administration Hospital in San Antonio, Texas. "Results from previous NewMet trials indicate that
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SOURCE Elcelyx Therapeutics
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