Arca Biopharma Inc (NASDAQ:ABIO), announced that 175 patients have been randomized into GENETIC-AF. It’s a unique design Phase 2B/3 clinical trial for the evaluation of a new drug – Gencaro (bucindolol hydrochloride, a beta blocker and a mild vasodilator) as a treatment of atrial fibrillation (AF) in cardiovascular patients.
ARCA is dedicated for applying a medicine approach for the purpose of developing genetically-targeted therapies, especially for cardiovascular patients. The company is pleased with the increased rate of patients into the GENETIC-AF trial, and believes that the reason is the need for new AF treatments, as per Dr. Michael Bristow, ARCA’s President and CEO.
GENETIC-AF Analysis Basis
Gencaro – the tested drug – is being evaluated in the GENETIC-AF, for its effectiveness in the prevention of atrial fibrillation or flutter in heart failure patients. Data safety Monitoring Board (DSMB) will carry out an analysis for Phase 2B in terms of efficacy, safety and futility, and the results are expected to be cleared out in the third quarter. This can be conducted when at least 150 patients generated evaluable data. This data is collected when randomized patients experience composite endpoint event, AF/AFL or all-cause mortality for the first time, or after the completion of the primary endpoint follow-up period of 24 weeks. The analysis will detect the evidence of superiority and safety of Gencaro relative to its cometitor, metoprolol succinate – known in market as Toprol-XL
It will result in one of three options: whether transition the trial to Phase 3, and that means success of Gencaro in terms of efficacy and safety. In this case Gencaro showed evidence of effectiveness consistent with pretrial assumptions. Second option is the completion of the Phase 2B stage including the 24-week follow-up in case of intermediate result. This means it’s favorable but not quite efficient to complete the transition to Phase 3. And the third option is futility, and this will require process termination. Most appropriate path will be determined based on DSMB recommendations according to the outcome of the analysis.
FDA offers Fast Track designation to patients with signals of improvement of serious symptoms with unmet medical need with other medication. The goal of the process is getting new drugs faster, since it allows the company to communicate with the FDA more frequently.