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ARCA prepares atrial fibrillation drug for Phase 3
September 2018
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WESTMINSTER, Colo.—ARCA biopharma Inc. reported recently that the FDA had issued guidance with regards to a Phase 3 program for Gencaro, ARCA’s pharmacologically unique beta-blocker, which is being advanced as a genetically targeted treatment for atrial fibrillation (AF) patients with heart failure (HF). The FDA has indicated that based on the results of the Phase 2 GENETIC-AF trial and previous Phase 3 pharmacogenetic substudy data, a single pivotal Phase 3 trial of Gencaro may be enough to support its approval in HF patients with AF. The FDA had previously given the Gencaro program Fast Track Designation, and more recently suggested that ARCA submit a Special Protocol Assessment application for the drug, which ARCA intends to do in Q3. ARCA noted in a press release that initiation of the Phase 3 trial will likely be subject to “securing additional financing through a strategic partnership and/or additional sales of the company’s securities.”

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