ARCA Biopharma Announces Third Quarter 2016 Financial Results And Provides Business Update

ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today reported financial results for the quarter ended September 30, 2016, and provided a business update.

"Atrial fibrillation is considered an epidemic cardiovascular disease impacting an estimated 33 million patients globally," commented Dr. Michael Bristow, ARCA's President and CEO. "Our on-going GENETIC-AF Phase 2B/3 clinical trial is evaluating Gencaro TM as potentially the first genetically-targeted treatment for atrial fibrillation. With the recent enrollment of the 125 th patient in the trial, we are approaching two important milestones - the enrollment of the 150 th patient, anticipated in the first quarter of 2017, and the outcome of the GENETIC-AF Data and Safety Monitoring Board Phase 2B interim efficacy analysis, projected in the third quarter of 2017. We believe there is an unmet medical need for new AF treatments that have fewer side effects than currently available therapies and are more effective, particularly in heart failure with reduced ejection fraction patients."

GENETIC-AF Clinical Trial

GENETIC-AF is a Phase 2B/Phase 3, multi-center, randomized, double-blind, adaptive design clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the treatment of atrial fibrillation (AF) in approximately 620 patients. Eligible patients will have heart failure with reduced left ventricular ejection fraction (HFREF), a history of paroxysmal AF (episodes lasting 7 days or less) or persistent AF (episodes lasting more than 7 days and less than 1 year) in the past 6 months, and the beta-1 389 arginine homozygous genotype that the Company believes responds most favorably to Gencaro. The primary endpoint of the study is time to first event of symptomatic AF/atrial flutter (AFL) or all-cause mortality. The combined Phase 2B/Phase 3 trial is designed for 90 percent power at a p-value of less than 0.01 significance level to detect a 25 percent reduction in the primary endpoint for patients in the Gencaro arm compared to patients in the Toprol-XL arm. The trial is currently enrolling patients in the United States, Canada and certain European countries. To date, 125 patients have been randomized into the trial.

If you liked this article you might like

4 Stocks Under $10 Making Big Up Moves on Big Volume

ARCA biopharma (ABIO) Stock Surges Today on FDA Fast Track Designation

3 Biotech Stocks Under $10 to Trade for Breakouts

5 Stocks Under $10 Set to Soar

Small-Cap Biotech on the Verge of a Breakout: ABIO