ARCA Biopharma announces FDA agreement for Phase 3 PRECISION-AF trial
ARCA Biopharma announced that it has reached agreement with the FDA regarding a special protocol assessment, or SPA, on the design of a Phase 3 clinical trial, PRECISION-AF, to assess the safety and efficacy of Gencaro as a genetically-targeted treatment for atrial fibrillation, or AF, in patients with a specific type of heart failure, or HF. The target population for the planned Phase 3 clinical trial, partially identified by precision therapeutic phenotyping, currently has no FDA approved drug therapies. This SPA provides agreement that the Phase 3 protocol design, clinical endpoints, trial population and statistical analyses adequately address objectives that, if met, would support a regulatory submission seeking approval of Gencaro for the prevention of AF recurrence in a genotype-defined HF population. In accordance with the company's SPA agreement with FDA, PRECISION-AF is designed as a single, adequate and well-controlled Phase 3 clinical trial that may be sufficient to support an new drug application, or NDA, submission for an AF indication if the objectives of the trial are achieved consistent with the requirements of the SPA. The trial is designed as a double-blind, active-controlled, multicenter, international study comparing Gencaro with Toprol-XL for the prevention of AF recurrence or all-cause mortality, or ACM, in HFmrEF patients. HFmrEF is defined as HF with a left ventricular ejection fraction, or LVEF, greater than 40% and less than 50%, which constituted approximately half of the enrolled population in the Phase 2 GENETIC-AF trial. PRECISION-AF is designed to enroll approximately 400 patients who have: HFmrEF, a recent AF event and the genotype which responds most favorably to Gencaro. The primary endpoint of the trial will be time to first event of atrial fibrillation/atrial flutter or ACM during the 26-week follow-up period. Subject to securing additional financing, ARCA anticipates initiating PRECISION-AF in Q4.