ARCA biopharma (NASDAQ: ABIO) this morning said the GENETIC-AF trial Data and Safety Monitoring Board (DSMB) has completed its pre-specified phase 2B interim analysis and has recommended completion of the study with no changes to the trial design. GENETIC-AF is a clinical trial evaluating Gencaro™ as a candidate for the treatment of atrial fibrillation (AF). The Gencaro development program has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). “The DSMB stated that there were no safety concerns and that the efficacy results met the prespecified criteria for continuing the Phase 2B trial to completion. We are pleased with the execution of the study thus far with major pretrial assumptions reflected in the trial to date, including genotype frequency, AF/AFL event rate and patient screening rates. We believe the DSMB recommendation is encouraging, as the trial is testing for superior efficacy over the active comparator, TOPROL-XL,” Dr. Michael Bristow, ARCA’s president and CEO, stated in the news release. “We are now focused on completing the Phase 2B trial, which we estimate should include approximately 50% more events than were available at the interim analysis. We look forward to sharing the top-line trial results late in the first quarter of next year, and reviewing the findings with the FDA.”
To view the full press release, visit http://nnw.fm/bW5Xl
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation and HFrEF, currently in a Phase 2B clinical trial. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. The Gencaro development program has been granted Fast Track designation by the FDA. For more information, please visit www.ARCABio.com.
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