Benzinga | Oct 28, 2021 05:18PM EDT

ARCA Biopharma Announces ASPEN-COVID-19 Data And Safety Monitoring Committee Recommends Continuing Phase 2b Clinical Trial To Completion Based On Interim Analysis Of Efficacy And Safety Data

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 the ASPEN-COVID-19 Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with severe COVID-19. The Company announced that the Data and Safety Monitoring Committee (DSMC) has completed a pre-specified interim analysis and, based on the DSMC's review of approximately 75% of the projected final efficacy and safety data, recommended completion of the clinical trial with no modifications to the trial design. The rNAPc2 development program has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The Company now anticipates completion of target enrollment of 160 patients by year end 2021 and reporting of topline data in the first quarter of 2022.

Dr. Michael Bristow, ARCA's President and Chief Executive Officer, commented, "Clearing the final interim analysis with no recommended changes in the Phase 2b clinical trial design is an important step in a clinical trial and in the development of rNAPc2 for prevention of COVID-19-associated coagulopathy. We are focused on finishing the clinical trial, which we estimate will complete enrollment by year end. We look forward to sharing the top-line trial results in the first quarter of next year and reviewing the findings with the FDA."