ARCA bio Updates on Phase 2b Trial of Potential Treatment for COVID-19

  ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today provided an update on ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19.

ARCA has received approval from regulatory authorities in Argentina and Brazil to enroll patients in ASPEN-COVID-19. The trial is currently enrolling patients at seven investigative sites in the United States. The Company anticipates enrolling the first South American patients in July 2021.

Trial target enrollment is being increased from 100 to 160 patients in order to maximize the sample size for determining if there are differences in the two rNAPc2 dose regimens being investigated, to minimize variance in the standard of care heparin control arm, in recognition of the study now being conducted in different geographic regions and to account for evolving changes in the clinical course of COVID-19. To date, 77 patients have been enrolled in the trial. The Company also updated its guidance and now anticipates topline data from this international Phase 2b clinical trial in the fourth quarter of 2021.

“With the pandemic continuing to impact patients around the world and the emergence of multiple variants, there remains a critical need for safe, efficacious treatments for hospitalized COVID-19 patients,” said Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator. “Many pathogenic viruses, including SARS-CoV-2, increase host cell expression of tissue factor, the primary initiator of the extrinsic coagulation pathway that also signals a parallel inflammatory response. rNAPc2 is a high affinity inhibitor of tissue factor, and with its combination of anticoagulant, anti-inflammatory and potential antiviral effects, we believe rNAPc2 may favorably impact clinical recovery of patients hospitalized with COVID-19, and thus has the potential to be a uniquely beneficial therapy for these patients, and possibly for other virus associated diseases. Argentina and Brazil are experiencing a higher COVID-19 case rate than the U.S. and, with their excellent investigators and track record in clinical trials, are logical countries in which to expand the Phase 2 trial and, ultimately, a potential Phase 3 trial.”

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.

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