Pharmaceutical Business review

CoGenesys gets FDA OK to test heart drug in humans

Cardeva, a long-acting form of b-type natriuretic peptide (BNP), is the most advanced compound in CoGenesys’ pipeline. Preclinical studies have demonstrated that Cardeva retains the pharmacological profile of BNP peptide but has a greatly extended half-life and long duration of action.

The phase I/II clinical trial of Cardeva will be an 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 and 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 Dr Jay Cohn, professor of medicine at the University of Minnesota. “Chronic administration of a long-acting BNP could have remarkably favorable effects that must be documented in clinical trials.”