SAN DIEGO, Sept. 4, 2013 /PRNewswire/ -- Elcelyx Therapeutics announced today that NewMet, the delayed-release formulation of generic metformin for the treatment of patients with Type 2 diabetes, met its primary study endpoint with statistically significant reductions in fasting plasma glucose at four weeks of treatment compared to placebo.
The results from the randomized, 240-patient, multicenter U.S. Phase 2b trial confirm previous studies that showed NewMet reduced fasting plasma glucose to a similar extent as generic metformin but at plasma exposure levels previously shown to be as much as 65% lower than comparable doses of generic metformin.
The double-blind, dose-finding trial evaluated NewMet once-daily doses of 1,000, 800 and 600 milligrams compared to placebo. There were also two comparator arms with Glucophage XR dosed once-daily at 1,000 and 2,000 milligrams. Secondary endpoints through 12 weeks include changes in fasting plasma glucose, hemoglobin A1c, body weight and measures of safety and tolerability. Twelve-week results are expected in late October.
The results at four weeks provide confirmation that the primary site of metformin activity is the lower bowel and not the circulation. The reduced systemic absorption of NewMet indicates that it may be an appropriate treatment for Type 2 diabetes patients who have renal impairment and are contraindicated for metformin use due to the risk of lactic acidosis, a life-threatening condition that can result from metformin build-up in the blood.
About Elcelyx Therapeutics, Inc.
Elcelyx Therapeutics is developing pharmaceutical product candidate NewMet for use by Type 2 diabetes patients who have difficulty tolerating generic metformin or are contraindicated for its use. NewMet presents a near-term, blockbuster commercial opportunity. Elcelyx is based in San Diego, CA. For more information, visit www.Elcelyx.com.
SOURCE Elcelyx Therapeutics