Gencaro, a pharmacologically unique beta-blocker and mild vasodilator, is being developed for the prevention of atrial fibrillation/atrial flutter (AF) in a genetically modified heart failure population (heart failure patients with reduced left ventricular ejection fraction or HFREF).
We note that the FDA grants Fast Track designation to those candidates that are being developed for the treatment of serious conditions with unmet medical need. The overall goal of the process is to get new drugs to patients faster. Fast Track status will allow the company to communicate with the FDA frequently throughout the development and review process, with the aim of expediting the candidate’s approval. Moreover, the company is eligible to make a rolling submission of its new drug application for the candidate, which will be considered for priority review.
Presently, Gencaro is being evaluated in a phase IIb/III study (GENETIC-AF) for the above mentioned indication. The company expects to complete patient enrolment in the phase IIb part of the study by the end of 2016.
ARCA biopharma has a collaboration with Medtronic MDT for the GENETIC-AF study.
We are encouraged by the FDA granting Fast Track designation to Gencaro. According to the company’s press release, AF is estimated to affect more than 2.7 million people in the U.S. with as many as 250,000 to 500,000 new cases being diagnosed each year.
Gencaro is the lead candidate in ARCA biopharma’s pipeline and we expect investor focus to remain on updates pertaining to its development.