FDA Grants Fast Track Designation to ARCA biopharma’s Potential COVID-19 Treatment

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.

On Nov. 23, 2020, ARCA biopharma, a US-based biopharmaceutical company specializing in a precision-medicine approach to developing cardiovascular therapeutics, announced that FDA has granted fast track designation for its investigational compound, AB201, a small recombinant fusion protein, for the potential treatment of COVID-19.

The company plans to initiate a Phase IIb clinical trial in December 2020 of the compound in approximately 100 patients hospitalized with COVID-19, with topline trial data anticipated in the second quarter of 2021. AB201 is a potent, selective inhibitor of tissue factor (TF), which plays a central role in the inflammatory response to viral infections.

“Fast [t]rack designation for the AB201 development program is an important acknowledgement of the critical need for treatments for hospitalized COVID-19 patients, whether effective vaccines are approved and available or not,” said Dr. Michael Bristow, ARCA’s president and CEO, in a company press release. “We believe AB201’s combination of anticoagulant, anti-inflammatory, and antiviral effects may favorably impact clinical recovery of patients hospitalized with COVID-19 and look forward to beginning the ASPEN-COVID-19 trial to evaluate AB201’s potential efficacy in this patient population.”

Source: ARCA biopharma