- The Knowledge and Security Monitoring Committee (DSMC) has accomplished a pre-specified interim evaluation for ARCA biopharma Inc’s (NASDAQ: ABIO) ASPEN-COVID-19 Section 2b trial evaluating rNAPc2, a small recombinant protein for COVID-19.
- Based mostly on the evaluate of roughly 75% of the projected ultimate efficacy and security information, DSMC really useful finishing the trial with no modifications to the trial design.
- The rNAPc2 growth program has been granted FDA Quick Monitor designation.
- The Firm anticipates finishing the goal enrollment of 160 sufferers by year-end 2021 and reporting topline information in Q1 of 2022.
- ASPEN-COVID-19 trial is evaluating two dose regimens of rNAPc2 versus heparin in hospitalized constructive sufferers who even have an elevated D-dimer stage.
- The trial’s main endpoint is the change in D-dimer stage from baseline to Day 8 relative to plain of care heparin.
- D-dimer is a biomarker generally used for assessing coagulation activation, which is elevated in roughly 40% to 75% of hospitalized COVID-19 sufferers and is related to opposed medical outcomes.
- Heparin is a generally used anticoagulant for COVID-19.
- Value Motion: ABIO shares are up 19.1% at $3.12 throughout the premarket session on the final test Friday.
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