Arca Biopharma Inc (NASDAQ:ABIO), a biopharmaceutical company that develops genetically-oriented therapies meant for treatment of cardiovascular diseases has announced randomizing the GENETIC-AF. GENETIC-AF is a Phase 2B/3 clinical trial that examines atrial fibrillation (AF) using Gencaro™.
Arca President and CEO Dr. Michael Bristow said they are pleased with increase in GENETIC-AF clinical trial enrolment. He adds that the increased enrollment reflects the demand gap for AF treatment among patients with heart failure.
The GENETIC-AF Data Safety Monitoring Board (DSMB) will carry out the Phase 2B clinical trial which is meant to establish the safety, efficacy and futility in at least 150 patients. The results for the trial will be out in the third quarter of 2017.
GENETIC-AF is a Phase 2B/3 trial conduct to evaluate Gencaro effectiveness to prevent the repeat of atrial fibrillation patients with heart failure and reduced left ventricular ejection fraction.
The DSMB carry out a pre-specified analysis to determine the safety and efficacy of in at least 150 patients with evaluable data. A randomized patient is said to have evaluable data when they either have their first composite endpoint point or after the 24week trial period. The analysis will be done to get supporting evidence of superior efficacy and safety of Gencaro against the metoprolol succinate (TOPROL-XL) that is primarily used.
Among the features defined in the trial is an estimate of the effectiveness of Gencaro in relation to TOPROL-XL as well as a study of the safety as exhibited in the adverse events. The estimated relative benefit will use the Bayesian statistical methods to determine the probability of Phase 3 patient cohort hazard ratio relative to Phase 2B interim data. Probability ranges have been predetermined so as to define the results of the Phase 2B interim study.
Arca in partnership with Steering Committee in charge of the trial will find the most preferable path for the trial basing on recommendations from the DSMB. The trial’s primary endpoint is the time taken before the first occurrence of symptomatic AF/AFL or all-cause mortality. The study is currently admitting patients in Canada, United States and Europe.