- Edesa Biotech Inc EDSA has announced positive results from the Phase 2 part of an ongoing Phase 2/3 study evaluating EB05 as a single-dose treatment for hospitalized COVID-19 patients.
- Related Link: Edesa Biotech Provides Update For COVID-19 Antibody Trial.
- An independent Data and Safety Monitoring Board (DSMB) said it identified an important signal between the treatment arms for 28-day mortality and requested that the study be preemptively unblinded.
- The DSMB concluded that "a clinically important efficacy signal" was detected and that the study has "met its objective."
- The DSMB further recommended the continuation of the study into a Phase 3 confirmatory trial.
- The DSMB reported a 28-day death rate of 14.3% (2/14) in the EB05 arm versus 36.8% (7/19) in the placebo arm.
- Patients treated with EB05 plus standard of care had a 68.5% reduction in the risk of dying compared to placebo plus standard of care at 28 days.
- EB05 was well-tolerated and consistent with the observed safety profile to date.
- Price Action: EDSA stock is up 40.8% at $8.28 during the market session on the last check Monday.
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