PhaseBio initiates Glymera Phase 1/2a clinical trial in patients with Type 2 diabetes

PhaseBio Pharmaceuticals, Inc.Dec 1 2010

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 begun Phase 1/2a clinical testing with its lead compound, Glymera^TM (PB1023), in patients with Type 2 diabetes. Glymera^TM is a novel recombinant glucagon-like peptide-1 (GLP-1) analog which has been genetically engineered in a highly efficient, low-cost, Escherichia coli expression system using the company's elastin-like biopolymer technology.

“If the clinical results are consistent with our non-clinical findings, GlymeraTM may prove to be an efficacious, more convenient, better-tolerated and less expensive treatment for Type 2 diabetes than the current GLP-1 receptor agonists. We look forward to completing this study next year.”

In non-clinical studies using models of diabetes, Glymera^TM demonstrated a prolonged steady-state circulation without the "burst" of drug levels seen with other products. This pharmacological profile may translate into more sustained glycemic control, better tolerability and once-weekly or less frequent dosing compared to commercially available GLP-1 receptor agonists which require daily injection(s) and do not maintain glycemic control for a full 24 hours.

"Glymera^TM appears to have a unique pharmacokinetic profile that makes it a very promising drug candidate for the treatment of Type 2 diabetes," said Dr. Craig Rosen, executive chairman and chief scientific officer of PhaseBio. "It is a product of our technology which appears to have broad application because it allows us to genetically fuse peptides, proteins and small molecules to an elastin-like biopolymer to prolong their activity and reduce their side effects. We are currently applying this technology to improve the stability, rate of absorption and half-life of GLP-1 and other therapeutic compounds. It is also compatible with multiple protein expression systems, can reduce the cost of manufacturing recombinant proteins and enables the use of liquid drug formulations that can be administered using a small-gauge needle."

The primary objective of this double-blind, placebo-controlled, single and multiple ascending-dose study is to evaluate the safety, pharmacokinetics and ability of once-weekly or less frequent subcutaneous doses of Glymera^TM to reduce fasting plasma glucose and glucose excursions following a glucose tolerance test with the goal of demonstrating continuous glycemic control for at least a full week following a single administration. The trial is being conducted at three U.S. study centers and is expected to be completed during the second half of 2011.

"We are excited to begin clinical testing of this investigational compound to explore its potential to reduce uncontrolled glucose excursions and maintain 24/7 glycemic control for at least one week in patients with Type 2 diabetes," said Lynne Georgopoulos, senior vice president of clinical development at PhaseBio. "If the clinical results are consistent with our non-clinical findings, Glymera^TM may prove to be an efficacious, more convenient, better-tolerated and less expensive treatment for Type 2 diabetes than the current GLP-1 receptor agonists. We look forward to completing this study next year."