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 begun dosing subjects in a Phase 1 clinical study with its novel compound, VasomeraTM (PB1046), in patients with Stage 1 and 2 essential hypertension. VasomeraTM is a VPAC2-selective Vasoactive Intestinal Peptide (VIP) agonist which has been genetically engineered using the company’s elastin-like biopolymer (ELP) technology to provide a long-acting, slow adsorption product profile that is being developed as an adjunctive therapy for the treatment of hypertension as well as for congestive heart failure, a common complication of chronically elevated blood pressure.
In preclinical studies using models of hypertension and heart failure, VasomeraTM demonstrated prolonged and significant dose dependent reductions in mean arterial pressure as well as positive inotropic and lusitropic effects without increasing myocardial oxygen consumption.
“VasomeraTM appears to have a unique mechanism of action that makes it a very promising drug candidate for the treatment of cardiovascular disease,” said Robert Hamlin, DVM, PhD, DACVIM, Stanton Youngberg Professor of Veterinary Medicine Professor of Biomedical Engineering at Ohio State and preclinical scientific advisor to PhaseBio.
The primary objective of this double-blind, placebo-controlled study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of single ascending doses of VasomeraTM administered subcutaneously to patients with essential hypertension. The trial is being conducted in the U.S. and is expected to be completed by the end of 2012.
“We are excited to begin clinical testing of this investigational compound. If the clinical results are consistent with the preclinical findings, VasomeraTM may prove to be a novel, first-in-class product that could address the currently unmet medical needs for the treatment of uncontrolled hypertension and heart failure,” said Henry R. Black, MD, Clinical Professor of Internal Medicine and Director of Hypertension Research at the New York University School of Medicine, New York, New York and clinical scientific advisor to PhaseBio.
“Along with our type 2 diabetes product, GlymeraTM, which recently completed a Phase IIa clinical study in October 2011, VasomeraTM further validates the broad applicability of our ELP technology to develop highly differentiated and improved biotherapeutic drugs for significant unmet medical needs,” said Craig Rosen, Executive Chairman and Chief Scientific Officer of PhaseBio.
PhaseBio Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel drugs to treat diabetes, metabolic and cardiovascular disease. The company uses elastin-like biopolymers (ELP’s) 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 providing 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 uncontrolled hypertension and heart failure, and Insumera™, a novel mature insulin ELP-fusion. PhaseBio is a privately owned company with headquarters and research laboratories in Malvern, Pennsylvania.