FDA OK’s Trial of CoGenesys’ Heart Drug

CoGenesys said Thursday the U.S. Food and Drug Administration has OK’d a phase 1/2 study of Cardeva, a potential drug for heart failure.

The study, which will begin soon, will involve 80 stable patients with class 2 or 3 heart failure. The subjects will receive one or two doses of Cardeva, a long-acting form of b-type natriuretic peptide, or BNP.

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, Dr. Jay N. Cohn, professor of medicine at the University of Minnesota, said in a statement released by CoGenesys. Chronic administration of a long-acting BNP could have remarkably favorable effects that must be documented in clinical trials, Cohn added.

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, said Dr. Martha A. Reitman, CoGenesys’ senior vice president of medical affairs. 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.