ARCA Biopharma Announces Positive Outcome of End-of-Phase 2 Meeting With FDA on Gencaro Development for Atrial Fibrillation

ARCA Biopharma (NASDAQ:ABIO) has announced it has received guidance from the US Food and Drug Administration (FDA) following an End-of-Phase 2 meeting regarding the Phase 32 program for its beta-blocker Gencaro as a potential genetically-targeted treatment for atrial fibrillation patients with heart failure.

As quoted in the press release:

Based on review of the Phase 2 GENETIC-AF trial results, as well as its alignment with previous Phase 3 pharmacogenetic substudy data, the FDA stated that data from a single pivotal Phase 3 clinical trial may be sufficient to support approval of Gencaro for the treatment of AF in patients with HF. The Company, in consultation with the FDA, has established key elements of the Phase 3 clinical trial needed to support a New Drug Application (NDA), details of which will be confirmed via the FDA Special Protocol Assessment (SPA) process.

The FDA previously granted the Gencaro atrial fibrillation development program Fast Track Designation. As the Gencaro program is developing potentially the first genetically-targeted cardiovascular therapy, the FDA has suggested the Company submit a SPA application, which the Company anticipates submitting in the third quarter of 2018.

ARCA anticipates initiating the Phase 3 clinical trial subject to securing additional financing through a strategic partnership and/or additional sales of the Company’s securities.

The pivotal Phase 3 clinical trial will likely entail a single randomized, active-controlled trial with the primary endpoint based primarily on AF Burden (AFB). AFB is defined as the amount of time per day a patient experienced AF, as measured by an implanted monitoring device. In the recently completed GENETIC-AF Phase 2B clinical trial, Gencaro showed a trend for 25% benefit over Toprol-XL in reducing AF recurrence as measured by AFB in a subgroup of patients with implanted devices in which AFB was monitored. For U.S. patients in this substudy, a trend for 51% benefit was observed.

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