FDA gives fast-track designation to Arca biopharma’s COVID treatment

WESTMINSTER — A potential therapy for severe COVID-19 patients being developed by Arca Biopharma Inc. (Nasdaq: ARCA) received a fast-track designation from the U.S. Food and Drug Administration.

An FDA fast-track designation allows recipients to request expedited review of clinical trial data and allows companies to submit portions of a new drug application in parts rather than all at once.

The Westminster company plans to begin recruitment for a Phase II trial of drug candidate AB-201  with 100 hospitalized patients next month. 

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AB-201 was first developed as an anti-blood-clotting agent for heart attack patients and already cleared Phase II trials for that purpose. In a statement, the company said AB-201 is likely the only anticoagulant being studied for use in COVID-19 with a fast-track designation.

This month, the company said it had $51.1 million in cash and equivalents on hand, enough to cover its expenses through the trial’s expected end date in mid-2021 and keep the company afloat through the end of 2022.