PhaseBio Pharmaceuticals has commenced patient dosing in a multicenter Phase 2b trial designed to evaluate the efficacy and safety of three doses of once weekly Glymera compared to matched placebo as well as an active comparator for the treatment of uncontrolled type 2 diabetes.
The randomised placebo and active comparator controlled Phase 2b trial, targeted to complete by third quarter 2013, will enroll approximately 600 patients with type 2 diabetes (hemoglobin A1c 7% – 11%) inadequately controlled with diet and exercise, metformin, a sulfonylurea or a combination of metformin/sulfonylurea.
PhaseBio chief scientific officer Craig Rosen said, “We are extremely pleased at the rapid progress we have made since our first IND filing in October 2010 to make once weekly Glymera a competitive player in the GLP-1 space, as evidenced by very strong efficacy data that gives us, as well as our investors, the confidence that we will be able to establish product differentiation from other GLP-1 agonists with improved tolerability and efficacy in this Phase 2b trial.”
As a result of encouraging Phase 1/2a results, PhaseBio raised an additional $23m in May 2012 in a third tranche of a Series B financing to support Phase 2b clinical testing of Glymera for the treatment of type 2 diabetes.
