Gencaro (bucindolol hydrochloride) for the treatment of patients with chronic heart failure by ARCA bioharma Inc has been granted fast track designation by US FDA.
ARCA biopharma intends to submit a study protocol for review under the FDA’s Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro.
ARCA will compare the efficacy of Gencaro (bucindolol hydrochloride) to the beta-blocker metoprolol CR/XL, which is approved for heart failure and other indications.
Gencaro (bucindolol hydrochloride) is a beta-blocker and mild vasodilator in an oral tablet formulation, dosed twice daily.
Gencaro is considered part of the beta-blocker class because of its property of blocking beta-1 as well as beta-2 receptors in the heart, preventing these receptors from binding with other molecules that would otherwise activate the receptor.
Because of Gencaro’s mild vasodilator effects, it is well-tolerated in patients with advanced heart failure.
The active pharmaceutical ingredient in Gencaro, bucindolol hydrochloride, has been tested clinically in approximately 3,000 patients.
Gencaro was the subject of a Phase 3 heart failure mortality trial of over 2,700 patients, mostly in the U.S., known as the “BEST” trial.
The BEST trial included a DNA bank of over 1,000 p
Comments are closed for this Article !