SAN DIEGO, Sept. 17, 2013 /PRNewswire/ -- Elcelyx Therapeutics today announced that clinical advisor, John Buse, M.D., Ph.D., will present clinical data for NewMet™, a delayed-release formulation of generic metformin, in an oral presentation at the 49th Annual European Association for the Study of Diabetes (EASD) Meeting in Barcelona, Spain. Dr. Buse, Professor of Medicine and Director, Diabetes Care Center, Chief, Division of Endocrinology, Executive Associate Dean for Clinical Research at University of North Carolina School of Medicine, will describe the results of Elcelyx's Phase 2a clinical trial that compared NewMet with generic metformin in patients with Type 2 diabetes.
The presentation at the Fira Barcelona Gran Via, Bernard Hall will take place as follows:
Dissociation between metformin plasma exposure and its glucose-lowering effect: A novel gut-mediated mechanism of action
- Date and Time: Thursday, September 26, 2013, 10:45 – 11:00 a.m. CEST
- Category: OP 25 Novel therapeutic agents and insights
- Oral Presentation #: 145
- Presenter: John Buse, M.D., Ph.D., Professor of Medicine and Director, Diabetes Care Center, Chief, Division of Endocrinology, Executive Associate Dean for Clinical Research at University of North Carolina School of Medicine, Chapel Hill, North Carolina
Elcelyx Therapeutics' pharmaceutical product candidate NewMet is a delayed-release formulation of metformin, the foundational treatment for Type 2 diabetes. By redesigning generic metformin to target 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. NewMet's improved safety and tolerability profile may make it appropriate for use by Type 2 diabetes patients who have difficulty tolerating generic metformin or are contraindicated due to renal impairment. A Phase 2b, 240-patient, multicenter dose-finding clinical trial is underway. The study has already met its primary endpoint with statistically significant reductions in fasting plasma glucose at four weeks of treatment compared to placebo. 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.
About Elcelyx Therapeutics
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