ARCA Biopharma Stock Gains As Safety Committee Recommends COVID-19 Trial To Continue Unchanged
The Data and Safety Monitoring Committee (DSMC) has completed a pre-specified interim analysis for ARCA biopharma Inc's (NASDAQ: ABIO) ASPEN-COVID-19 Phase 2b trial evaluating rNAPc2, a small recombinant protein for COVID-19.
Based on the review of approximately 75% of the projected final efficacy and safety data, DSMC recommended completing the trial with no modifications to the trial design.
The rNAPc2 development program has been granted FDA Fast Track designation.
The Company anticipates completing the target enrollment of 160 patients by year-end 2021 and reporting topline data in Q1 of 2022.
ASPEN-COVID-19 trial is evaluating two dose regimens of rNAPc2 versus heparin in hospitalized positive patients who also have an elevated D-dimer level.
The trial's primary endpoint 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 a commonly used anticoagulant for COVID-19.
Price Action: ABIO shares are up 19.1% at $3.12 during the premarket session on the last check Friday.
See more from Benzinga
Medtronic To Face Class Action Suit From Canadian Users Of MiniMed Insulin Pumps
FDA Restricts Sale, Approves New Labeling Of Breast Implants
© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
