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.
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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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By GlobalDataThe 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
