ARCA biopharma, Inc. (NASDAQ:ABIO) Files An 8-K Other Events

On September 21, 2020, ARCA biopharma, Inc., or the Company, announced it has submitted an Investigational New Drug, or IND, application with the U.S. Food and Drug Administration, or FDA, under the Coronavirus Treatment Acceleration Program for AB201 as a potential treatment for patients with COVID-19. Pending FDA feedback, the Company anticipates initiating the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 as early as the fourth quarter of this year. The press release related to these items is filed as Exhibit 99.1 hereto, the contents of which are incorporated herein by reference.

Section 9 — Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

ARCA biopharma, Inc. Exhibit
EX-99.1 2 abio-ex991_6.htm EX-99.1 abio-ex991_6.htm   Exhibit 99.1         ARCA biopharma Announces Submission of IND Application to U.S. FDA for AB201 as a Potential Treatment for covid-19   Westminster,…
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About ARCA biopharma, Inc. (NASDAQ:ABIO)

ARCA biopharma, Inc. (ARCA) is a biopharmaceutical company. The Company is principally focused on developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate is Gencaro (bucindolol hydrochloride), a beta-blocker and mild vasodilator that the Company is evaluating in a clinical trial for the treatment of atrial fibrillation (AF) in patients with heart failure with reduced left ventricular ejection fraction (HFREF). Gencaro is considered part of the beta-blocker class of compounds because of its property of blocking both beta-1 and beta-2, receptors in the heart. The blocking of these receptors prevents the receptor from binding with other molecules, primarily the neurotransmitter norepinephrine (NE), which activate these receptors. The Company is conducting a Phase IIB/III clinical trial of Gencaro, known as GENETIC-AF.