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ARCA Biopharma submits anti-blood clotting drug to FDA as potential COVID treatment

WESTMINSTER — Gene therapy maker ARCA biopharma Inc. (Nasdaq: ABIO) has filed an initial application to study whether its anti-blood clotting drug candidate could be used to treat a severe side effect in COVID-19 patients. The Westminster company said it asked permission to start clinical trials on the drug, designated as AB201, under a U.S. Food and Drug Administration program to fast-track COVID-related treatments. That permission is required before a drug developer can start administering an experimental treatment to humans or ship it across state lines. AB201 was originally conceived as an anti-blood clotting agent for heart attack patients and already cleared Phase II trials for that purpose. Those same properties are thought to be of potential value to COVID-19 patients whose immune systems are inducing blood clots or other inflammatory responses that create life-threatening side effects. In a statement, Arca president and CEO Michael Bristow said the drug could also be deployed to treat clotting caused by other viruses with RNA as their main genetic material. “With what we believe to be a strong scientific rationale, safety data from prior human clinical trials in over 700 patients, and a well-defined regulatory pathway, we believe AB201 has potential as a therapeutic treatment for COVID-19,” he said. If approved, Arca believes it could start the first portion of a combined Phase II/III trial as soon as October. © 2020 BizWest Media LLC
Source: BizWest

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