ARCA gets FDA nod to test anti-clotting drug for COVID patients

WESTMINSTER — ARCA Biopharma Inc. (Nasdaq: ARCA) received approval from the U.S. Food and Drug Administration to begin an advanced clinical trial to determine if its anti-blood clotting drug candidate could be used to treat severe COVID-19.

In a statement, the Westminster company said that it will begin recruitment for 100 hospitalized patients in December and plans to release initial results in the second quarter of 2021.

AB201 was first developed as an anti-blood-clotting agent for heart attack patients and already cleared Phase II trials for that purpose. Its mechanism of action is to inhibit the D-dimer biomarker, which is thought to lead to elevated clotting.

However, Arca believes that the therapy could benefit COVID-19 patients whose immune systems are inducing blood clots or other inflammatory responses that create life-threatening side effects.

“We believe that the combination of anticoagulant, anti-inflammatory and antiviral effects of AB201 may favorably impact clinical recovery of patients hospitalized with COVID-19,” CEO Michael Bristow said in a statement.

While that mid-2021 data release is well within predictions of when a COVID vaccine will be approved, company spokesperson Derek Cole said certain people may not be able to take it due to existing medical conditions and have to wait for a vaccine with a different approach.

He also said the research into COVID-19 could be transferred to other RNA-based viral diseases, ranging from certain common colds to SARS.

“The development program we’re doing would still provide us a significant amount of disease data, for looking at treating RNA virus-associated diseases,” he said.

Separately, the company said it had $51.1 million in cash and equivalents on hand as of Sept. 30 as a preview for its third-quarter earnings later this year.

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