Investment Research and Business Due Diligence
Thursday, September 5, 2013
New Metformin for renally impaired Type 2 diabetes patients crosses Phase 2 trial hurdle
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.
Elcelyx has not changed the way metformin works but instead, has discovered
metformin works and leverages this understanding to develop an improved product. Rather than acting through the circulation, Elcelyx proposes that metformin acts at the lower bowel to activate signals leading to glucose regulation. NewMet targets the lower bowel, maintaining metformin’s effect on glucose, but significantly reducing bioavailability, which minimizes systemic exposure.
This improved safety and tolerability profile makes NewMet appropriate for patients who desire the glucose control of metformin with reduced gastrointestinal side effects or the need for titration. Renally impaired patients, currently contraindicated for metformin use, may benefit from NewMet’s much lower exposure. Because NewMet can deliver a maximally effective dose of metformin, it is an ideal candidate for fixed-dose combinations with other oral antidiabetic agents. NewMet offers the potential to be the only metformin/DPP4i FDC with a full effective metformin dose in a once-daily formulation not requiring titration.
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