NewMet™ “Metformin Reinvented for the 21st Century”
Pharmaceutical product candidate NewMet is a delayed-release formulation of metformin, the foundational treatment for Type 2 diabetes. NewMet offers best-in-class glucose control by reducing metformin’s gastro-intestinal side effects in a once-daily, low-dose tablet that does not require titration for initiation of treatment.
Elcelyx has not changed the way metformin works but instead, has discovered how 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.
In a recently completed Phase 2a clinical study in patients with Type 2 diabetes, NewMet met the primary endpoint of lowered glucose and demonstrated improved tolerability compared to generic metformin.
The Diabetes Epidemic
Type 2 Diabetes
In the U.S., an estimated 26 million people have type 2 diabetes1 and one new case is diagnosed every 37 seconds. It is the fifth leading cause of death and the primary cause of blindness, renal failure and lower extremity amputations. Worldwide, over 300 million people have Type 2 diabetes. Although there are effective therapies available, most diabetic patients do not achieve therapeutic goals due to lack of fully efficacious, tolerable therapies. Given this enormous prevalence, the need for additional therapeutic tools, and particularly therapeutic options with strong safety profiles, has never been greater.
More than 60 million people in the U.S. have pre-diabetes, characterized as glucose levels higher than normal but not high enough to be called diabetes, and approximately 8 percent progress to Type 2 diabetes each year. While diet and exercise have been shown to slow this rate of progression, in practice, the success rate is poor. There are currently no FDA approved treatments for the prevention of diabetes.