NEW YORK (TheStreet) -- Shares of ARCA biopharma (ABIO) - Get ARCA biopharma, Inc. Report surged 22.63% to $1.03 in afternoon trading Monday after the company announced that the Food and Drug Administration had designated as a Fast Track development program the investigation of Gencaro.
Gencaro is the company's investigational beta-blocker and mild vasodilator for the prevention of atrial fibrillation, or atrial flutter, in a genetically modified heart failure population, or heart failure patients with reduced left ventricular ejection fraction (HFREF).
Fast Track programs are designed to assist the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, along with those that demonstrate the potential to address unmet medical needs, according to the FDA's Fast Track Guidance documentation.
ARCA is evaluating Gencaro as a possible treatment for atrial fibrillation in a genetically-defined heart failure (HFREF) population in GENETIC-AF via a Phase 2B/3 adaptive design clinical trial. ARCA expects to enroll approximately 200 patients in the Phase 2B portion of the trial, which it expects to complete by the end of 2016.
"We view Fast Track designation for the Gencaro development program as an important acknowledgement of the need for advancements in the treatment of atrial fibrillation in heart failure patients," said ARCA President and CEO Michael R. Bristow in a statement.
"Atrial fibrillation afflicts over 2.7 million people in the United States with 250,000 to 500,000 new cases diagnosed each year," he continued. "We believe we have a significant opportunity to improve the treatment options for heart failure patients living with atrial fibrillation."