ARCA biopharma has reported that its Phase IIb ASPEN-COVID-19 clinical trial of the small recombinant protein, rNAPc2 (AB201), will progress without amendments.
The development comes after the Data and Safety Monitoring Committee (DSMC) conducted a pre-specified interim assessment and recommended completion of the trial without any modifications to the study design.
rNAPc2 is a selective tissue factor (TF) inhibitor and is claimed to possess anti-inflammatory, anti-coagulant and anti-viral properties. It is to be used as a treatment for hospitalised individuals with severe Covid-19,
The global multicentre, randomised Phase IIb trial is analysing two rNAPc2 dose schedules as against anti-coagulant, heparin, in nearly 160 Covid-infected subjects with high D-dimer levels.
The change in D-dimer level from baseline to day eight versus heparin is the primary goal of the trial.
Other goals of the trial include assessing safety, determining the appropriate dose regimen of rNAPc2 for a prospective Phase III trial and analysing various other clinical goals.
The company plans to conclude enrolment by the end of this year and report topline trial data in the first quarter of next year.
ARCA biopharma president and CEO Dr Michael Bristow said: “Clearing the final interim analysis with no recommended changes in the Phase IIb clinical trial design is an important step in a clinical trial and in the development of rNAPc2 for prevention of Covid-19-associated coagulopathy.
“We look forward to sharing the top-line trial results in the first quarter of next year and reviewing the findings with the FDA.”
In July, ARCA biopharma obtained approval from the regulatory agencies in Argentina and Brazil to initiate enrolment in Phase IIb trial of rNAPc2.