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ARCA biopharma Announces First Patients Enrolled in ASPEN-COVID-19 Phase 2b Clinical Trial Evaluating rNAPc2 (AB201) as a Potential Treatment for COVID-19
rNAPc2 development focused on unmet need for treatments in hospitalized COVID-19 patients, including after availability of vaccinesrNAPc2 is the only novel
About this update from Oruka Therapeutics, Inc.
[{"type":"text","content":"rNAPc2 development focused on unmet need for treatments in hospitalized COVID-19 patients, including after availability of vaccinesrNAPc2 is the only novel compound being developed for COVID-19 Associated CoagulopathyTopline trial data anticipated in the second quarter of 2021Data from this development program will also inform potential development in additional RNA virus-associated diseases WESTMINSTER, Colo., Dec. 15, 2020 (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 patients have been enrolled in ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 (AB201) as a potential treatment for patients hospitalized with COVID-19. The first patient was enrolled at the University of Colorado Hospital on December 10, 2020, with a total of 5 patients randomized to date. The Company currently anticipates topline trial data from this Phase 2b clinical trial in the second quarter of 2021. “There is a critical need for safe, efficacious treatments in hospitalized COVID-19 patients, and we believe this need will continue even with potentially effective vaccines available,” said Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator. “We believe rNAPc2’s combination of anticoagulant, anti-inflammatory and antiviral effects may favorably impact clinical recovery of patients hospitalized with COVID-19, and we look forward to completing the ASPEN-COVID-19 trial evaluating rNAPc2’s potential efficacy in this patient population.\" ASPEN-COVID-19 Phase 2b is a randomized, multi-center, international clinical trial evaluating two dose regimens of rNAPc2 versus heparin prescribed per local standard of care in approximately 100 hospitalized SARS-CoV-2 positive patients that also have an elevated D-dimer level. The primary endpoint of the trial is safety and 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 50% of hospitalized COVID-19 patients and is directly associated with adverse clinical outcomes. Dr. Wolfram Ruf, Scientific Direc...