MALVERN, Pa.--(BUSINESS WIRE)--PhaseBio Pharmaceuticals, Inc., a privately held, clinical-stage biotechnology company developing drugs to treat diabetes, metabolic disease and cardiovascular disease, announced today that it has initiated dosing in a multicenter (USA), randomized, placebo and active comparator controlled Phase 2b study that 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. The study will evaluate the efficacy and safety of three doses of once weekly Glymera compared to matched placebo as well as an active comparator. This study is targeted to complete by 3Q2013.
As a result of very promising Phase 1/2a results (data presented at American Diabetes Association Meeting, June 2012), PhaseBio raised an additional $23 million 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. This brought to a total of $48.4 million the amount raised from the Series B, which was led by New Enterprise Associates with participation by Hatteras Venture Partners, Johnson & Johnson Development Corporation, Astellas Venture Management and Fletcher Spaght Ventures.
“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,” says Craig Rosen, PhD, Chief Scientific Officer, PhaseBio.
PhaseBio Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel drugs to treat diabetes, metabolic and cardiovascular disease. The company’s proprietary platform technology uses elastin-like biopolymers (ELPs) to increase the half-life, bioavailability, efficacy and ease of administration of therapeutic drugs and to reduce their side effects. ELPs have been engineered to control the rate of absorption into the circulation, which results in a steady state pharmacokinetic profile, exhibiting a unique combination of slow absorption and prolonged half-life to provide an optimal drug exposure. The company’s lead development candidates are Glymera, a GLP-1 analogue for type 2 diabetes, Vasomera, a vasoactive intestinal peptide (VIP) agonist for acute and chronic heart failure and pulmonary arterial hypertension, and Insumera, a novel mature insulin ELP-fusion. PhaseBio is a privately owned company with headquarters and research laboratories in Malvern, Pennsylvania.