Fifty patients have been enrolled in Arca’s GENETIC-AF phase 2B/3 clinical trial. This trial evaluates bucindolol hydrochloride (Gencaro) as a potential genetically-targeted treatment for the prevention of atrial fibrillation.
“We are pleased with the clinical investigator support for the GENETIC-AF trial,” comments Michael Bristow, ARCA’s president and chief executive officer. “Under the revised trial protocol, which broadened the target patient population, patient enrolment in the trial has increased steadily over the past several months. We expect the DSMB interim analysis of phase 2B efficacy data, and the potential DSMB recommendation to convert the trial to a pivotal Phase 3 trial, to occur in the first half of 2017.”
There are currently 60 clinical trial sites in the United States and Canada, with five additional sites in start-up.
GENETIC-AF trial phase 2B prospective timeline:
- March 2015: Revised protocol distributed to participating clinical trial sites
- May 2015: GENETIC-AF Trial Investigators meeting and training
- May 2015: First trial sites operating under revised protocol
- Fourth quarter 2015: Approximately 65 clinical trial sites in USA & Canada
- January 2016: first 50 patients enrolled in trial January 2016
- Year end 2016: Sufficient enrolment for phase 2B DSMB interim efficacy analysis
- First half of 2017: DSMB interim analysis decision