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ARCA biopharma Announces Enrollment of First International Patient in Phase 2b Clinical Trial Evaluating rNAPc2 as a Potential Treatment for COVID-19
First international patient enrolled in BrazilTrial approximately 75% enrolledrNAPc2 development focused on unmet need for treatments in hospitalized COVID-19
About this update from Oruka Therapeutics, Inc.
[{"type":"text","content":"First international patient enrolled in BrazilTrial approximately 75% enrolledrNAPc2 development focused on unmet need for treatments in hospitalized COVID-19 patientsTopline trial data anticipated in the fourth quarter of 2021 WESTMINSTER, Colo., Sept. 16, 2021 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that the first international patient has been enrolled in ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19. The patient was enrolled in Brazil. ARCA also plans to enroll patients from Argentina and is currently enrolling patients at multiple sites in the United States. The international Phase 2b trial is approximately 75% enrolled as of this date. The Company currently anticipates topline trial data in the fourth quarter of 2021. “The expansion of ASPEN-COVID-19 to trial sites in South America and the enrollment of the first patient in Brazil add further momentum to rNAPc2’s clinical development focused on addressing the 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. “With its combination of anticoagulant, anti-inflammatory and potential antiviral effects, 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 as well. We look forward to working with the excellent investigators at our trial sites in Argentina and Brazil and, assuming enrollment continues to go well, to sharing the results of this important study in the fourth quarter.” ASPEN-COVID-19 is a Phase 2b randomized, multi-center, international clinical trial evaluating two dose regimens of rNAPc2 versus heparin in approximately 160 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. Other objectives of Phase 2b are to assess s...