ARCA biopharma, Inc. announced that enrollment has been completed in ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19.  160 patients were enrolled at clinical investigative sites in the United States, Argentina and Brazil. The Company anticipates reporting topline data from the clinical trial in the first quarter of 2022.

ASPEN-COVID-19 is a Phase 2b randomized, multi-center, international clinical trial evaluating two dose regimens of rNAPc2 versus heparin in hospitalized SARS-CoV-2 positive patients that also have an elevated D-dimer level. The primary endpoint of the trial is the change in D-dimer level from baseline to Day 8 relative to standard of care heparin. D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 40% to 75% of hospitalized COVID-19 patients and is associated with adverse clinical outcomes.  

Heparin is an anticoagulant commonly given to any patient hospitalized in the United States for COVID-19.  Other objectives of Phase 2b are to assess safety, determine the optimal dose regimen of rNAPc2 for a potential Phase 3 clinical trial and evaluate multiple additional clinical endpoints. Detailed information about the ASPEN-COVID-19 clinical trial is available at its listing on clinicaltrials.gov.

Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “Completing enrollment in ASPEN-COVID-19 is a significant milestone for the development of rNAPc2 as a potential treatment option for patients hospitalized 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.”

The U.S. Food and Drug Administration (FDA) has designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program. ARCA believes that rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19.