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 unnecessary systemic exposure and decreasing 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 innovative product that meets the needs of the marketplace.  Rather than acting through the circulation, Elcelyx has demonstrated that metformin acts at the lower bowel to activate signals leading to glucose regulation.

NewMet is delivered to the lower bowel, maintaining metformin’s effect on glucose, but significantly reducing systemic exposure.  This reduction in systemic exposure allows for metformin use in type 2 patients with moderate to severe renal impairment, a population that is presently contraindicated for metformin use.  Also, because metformin is not wasted to circulation, lower doses can be used and with bypassing the upper GI, improvements in tolerance can be realized without titration.

This improved safety and tolerability profile makes NewMet appropriate for patients who are currently contraindicated for metformin and those who desire the glucose control of metformin with reduced gastrointestinal side effects, both significant sub-populations of the type 2 diabetes market. 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 fully-effective metformin dose in a once-daily formulation not requiring titration.

In a recently completed 12-week Phase 2a clinical study in 240 subjects with Type 2 diabetes, NewMet demonstrated statistically significant reduction in fasting plasma glucose at four weeks as compared to placebo. The 12-week data confirm the durability of the effect observed at four weeks.