CoGenesys, Inc. announced that the US Food and Drug Administration has completed its review of the company's Investigational New Drug (IND) application for Cardeva, a long-acting form of b-type natriuretic peptide (BNP), and that the company intends to begin clinical testing in the United States shortly, pending institutional review board approval. Cardeva is the most advanced compound in CoGenesys' broad pipeline of improved, long-acting biopharmaceuticals being developed to address unmet medical needs across a broad spectrum of therapeutic areas.
Preclinical studies have demonstrated that Cardeva, a human serum albumin (HSA)-BNP fusion protein, retains the pharmacological profile of BNP peptide but has a greatly extended half-life and long duration of action. The phase I -2 clinical trial of Cardeva will be a randomized, multicenter, double-blind, vehicle-controlled, ascending repeat dose safety and tolerability trial in up to 80 stable subjects with class II or III heart failure. Subjects will receive one or two doses of Cardeva. Evaluations will include safety and tolerability, pharmacokinetic profiles, and signals for effect.
"BNP stimulates cyclic GMP, which is not only a vasodilator but an inhibitor of the progressive heart muscle structural remodeling that leads to progression of heart failure," according to Jay N. Cohn, M.D., Professor of Medicine at the University of Minnesota. "Chronic administration of a long-acting BNP could have remarkably favourable effects that must be documented in clinical trials," he said.
Martha A. Reitman, M.D., CoGenesys' Senior Vice President, Medical Affairs, stated, "We are pleased to announce the initiation of the clinical programme for Cardeva, which we believe holds great promise in the treatment of CHF. Heart failure patients with significant decompensation are currently only able to receive a short-acting BNP intravenously, usually in a hospital setting, to improve their clinical status. With Cardeva, our goal is to provide a low-dose, subcutaneous administration allowing for chronic outpatient treatment that will improve quality of life and decrease the incidence of acute decompensation and hospitalization."