- Molecular Partners AG MOLN has announced that a planned futility analysis of ensovibep in the Phase 3 ACTIV-3 study has not met the thresholds required to continue enrollment of hospitalized adults with COVID-19.
- The independent Data and Safety Monitoring Board (DSMB) recommends discontinuing recruitment in the ensovibep arm of the ACTIV-3 study conducted by the National Institutes of Health (NIH).
- ACTIV is evaluating multiple therapies for COVID-19.
- At the time of the analysis, 470 patients had been randomized in the ensovibep arm of the study.
- Ensovibep was observed to be generally safe and well-tolerated with reported side effects consistent with the standard of care.
- Molecular Partners and Novartis AG NVS are collaborating on developing ensovibep to assess ensovibep's ability to rapidly reduce viral load and prevent worsening symptoms of hospitalized COVID-19 patients.
- Novartis is conducting an EMPATHY Phase 2/3 trial with Molecular Partners as a sponsor, with topline interim data for the first 400 patients expected in early 2022.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: MOLN shares are down 36.3% at $9.42 during the premarket session on the last check Tuesday.
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