ARCA biopharma has obtained approval from the regulatory agencies in Argentina and Brazil to initiate enrolment in Phase IIb ASPEN-COVID-19 clinical trial of its small recombinant protein, rNAPc2.
Designed to selectively block tissue factors, rNAPC2 is being developed as a potential therapy for ribonucleic acid (RNA) virus-linked diseases, with a focus on Covid-19.
The therapeutic’s mechanism of action offers anti-coagulant, anti-inflammatory and anti-viral properties to potentially target viral infections from different pathways.
The randomised, multi-centre, global Phase IIb trial will assess two dosing regimens of rNAPc2 compared to heparin in hospitalised Covid-19 patients with high D-dimer levels.
A biomarker of coagulation activation, D-dimer is observed to be high in nearly half of the hospitalised Covid-19 patients and is directly related to adverse clinical outcomes.
The change in D-dimer level from baseline to day eight on receiving rNAPc2 versus heparin will be the trial’s primary goal.
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Safety and establishing the ideal rNAPc2 dosing regimen for Phase III will be the other trial goals.
The subject enrolment for the trial in Argentina and Brazil will commence this month. The ASPEN-COVID-19 trial is currently enrolling subjects at seven trial centres in the US.
With the trial extension, target enrolment will rise from 100 to 160 subjects to expand the sample size.
This increased sample size will aid in checking any differences between two dosing regimens of rNAPc2, to reduce variance in the standard of care heparin control arm, to include various geographic areas and to consider evolving changes in the clinical course of Covid-19.
A total of 77 subjects have so far been recruited for the trial. After updating the guidance, ARCA expects top-line results from the Phase IIb trial in the fourth quarter of this year.
ARCA biopharma president and CEO Dr Michael Bristow said: “Argentina and Brazil are experiencing a higher Covid-19 case rate than the US and, with their excellent investigators and track record in clinical trials, are logical countries in which to expand the Phase II trial and, ultimately, a potential Phase III trial.”
The company secured the US Food and Drug Administration approval for the trial in October 2020.