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ARCA Biopharma files to commence AB201 study for COVID-19

September 21, 2020

ARCA Biopharma (NASDAQ:ABIO) has submitted an Investigational New Drug application under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of patients hospitalized with COVID-19.

Pending FDA feedback, ARCA anticipates to initiate the Phase 2b portion of a sequential Phase 2b/3 of AB201 as early as the fourth quarter of this year.

AB201 is a small recombinant protein being developed as a potential treatment for RNA virus- associated disease, initially focusing on COVID-19.

Last month, the company concluded talks with the FDA to clarify a development path for the drug candidate.

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