ARCA biopharma has completed participants enrolment in the Phase IIb ASPEN-COVID-19 clinical trial of its small recombinant protein, rNAPc2, to treat hospitalised patients.
The latest move comes after the receipt of Argentina and Brazil’s regulatory agencies approval in July 2021 to begin enrolment in the countries.
The global, multi-centre, randomised clinical trial has enrolled 160 participants at clinical investigative sites in Argentina, Brazil, and the US.
It will assess two dose levels of the small recombinant protein versus heparin in hospitalised Covid-19 patients with a high D-dimer level.
A biomarker, D-dimer is usually used for coagulation activation assessment, which is related to adverse clinical outcomes.
It is observed to be high in 40% to 75% of hospitalised Covid-19 patients.
The D-dimer level change from baseline to day eight on receiving rNAPc2 compared to heparin will be the primary goal of the study.
Determining the optimal rNAPc2 dose regimen for a potential Phase III clinical trial and assessment of safety will be some of the other goals of the clinical trial.
ARCA biopharma president and CEO Dr Michael Bristow said: “Completing enrolment in ASPEN-Covid-19 is a significant milestone for the development of rNAPc2 as a potential treatment option for patients hospitalised with Covid-19 who have biomarker evidence of coagulopathy.
“We are grateful to the patients, their families, investigators and clinical research sites that are participating in the trial. We look forward to sharing the top-line trial results in the first quarter of next year and reviewing the findings with the FDA.”
rNAPc2 has been designed to selectively block tissue factors (TF). It is being developed as a potential therapy for Covid-19, as well as other viral diseases.