PhaseBio Pharmaceuticals, a clinical-stage biotechnology company, has begun patient dosing in a multicentre Phase IIb trial to evaluate use of Glymera for the treatment of uncontrolled type 2 diabetes.
The randomised placebo and active comparator controlled Phase IIb trial is designed to evaluate the efficacy and safety of three doses of once-weekly Glymera, compared to a matched placebo and an active comparator.
PhaseBio chief scientific officer Dr 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 IIb trial."
The study, which will enrol 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, is expected to completed by the third quarter of 2013.
As a result of encouraging Phase I/IIa results, PhaseBio raised an additional $23m in May 2012 to support Phase IIb clinical testing of Glymera for the treatment of type 2 diabetes.
Diabetes mellitus type 2, formerly non-insulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes, is a metabolic disorder characterised by high blood glucose, insulin resistance and relative insulin deficiency.