The US Food and Drug Administration (FDA) has approved the investigational new drug (IND) application of ARCA biopharma’s potential drug candidate AB201 (rNAPc2) to treat hospitalised patients with Covid-19.

A small recombinant protein, AB201 acts as a potent tissue factor inhibitor that exhibits anticoagulant, anti-inflammatory, and antiviral properties.

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Last month, ARCA filed the IND application with the FDA to conduct a Phase IIb/III trial of AB201 in hospitalised Covid-19 patients.

ARCA plans to start the sequential Phase IIb/III ASPEN-COVID-19 study of the drug candidate in around 100 patients in the fourth quarter of this year.

A Phase III trial will follow the Phase IIb study and will be based on Phase II data. ARCA expects top-line results from the trial in the second quarter of next year.

The randomised Phase IIb trial will compare two AB201 dose regimens to heparin prescribed according to local standard of care.

The trial’s primary endpoint will be a change in D-dimer level from baseline to the eighth day. D-dimer is a biomarker of coagulation activation, which increases in about 50% of hospitalised Covid-19 patients and is directly linked to adverse clinical outcomes.

On obtaining favourable D-dimer levels, subsequent FDA review of the findings and dose selection for Phase III, ARCA plans to begin enrolling 450 participants for the Phase III trial.

The primary endpoint of the Phase III trial will be clinical recovery, determined by the Adaptive COVID-19 Treatment Trial (ACTT-1) ordinal scale, while secondary endpoints include D-dimer levels and the number of thrombotic events.

ARCA biopharma president and CEO Dr Michael Bristow said: “The ASPEN-COVID-19 trial will use the coagulopathy biomarker D-dimer to identify an optimal dose from AB201 regimens that are both within the therapeutic range as determined from Phase II trials investigating cardiovascular thrombosis prophylaxis.

“If successful, we anticipate using this dose in a planned Phase III trial to evaluate potential improvement in clinical outcomes.”

The trial is being performed in partnership with the Colorado Prevention Center (CPC) and the University of Colorado’s Academic Research Organisation.