ARCA biopharma has announced the randomisation of the first European patients in the GENETIC-AF Phase 2B/3 clinical trial.
Patients in the US and Canada have been enrolled in the study, which is evaluating pharmacologically unique beta-blocker and mild vasodilator Gencaro as a potential treatment for atrial fibrillation (AF). Approximately six million patients in Europe are effected by the condition.
ARCA has identified common genetic variations, which predict individual patient response to Gencaro. This gives it the potential to be the first genetically-targeted therapy for the prevention of AF.
ARCA biopharma's president and CEO Michael R. Bristow said: “We are excited to expand the GENETIC-AF trial to European investigative sites that have expressed interest in participating in the on-going trial.
“We expect that the additional investigative sites in certain European countries will support the latter part of Phase 2B, and potentially the Phase 3 stage, of the trial. We believe inclusion of European investigative sites may also support potential European regulatory submissions and on-going business development activity.”
As per the current enrolment rate, the company expects to randomise at least 150 patients into the trial by the end of this year. The GENETIC-AF Data Safety Monitoring Board (DSMB) will carry out an interim efficacy, safety, and futility analysis of data from at least 150 patients with evaluable data.
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The firm expects the outcome of this interim analysis in the Q2 of next year.
Image: ARCA biopharma president and CEO Dr. Michael R Bristow. Photo: Courtesy of Businesswire/ARCA biopharma