Health Canada has approved to test Edesa Biotech Inc's (NASDAQ:EDSA) monoclonal antibody candidate, designated EB05, as COVID-19 rescue therapy for critically ill patients in the Phase 3 part of a Phase 2/3 clinical study.
- Approval of the company's Phase 3 study design follows favorable Phase 2 results, demonstrating preliminary evidence of EB05's ability to reduce mortality in the sickest patients.
- Among the results, critically ill hospitalized COVID-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying compared to placebo plus standard of care at 28 days.
- Related: Edesa Biotech Shares Gain As Its COVID-19 Antibody Shows Favorable Mortality Reductions.
- The Phase 3 study is designed to assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus organ support (IMV+).
- The primary endpoint will be 28-day mortality. Ventilator-free days and 60-day mortality will also be measured.
- The amended trial protocol design calls for approximately 315 evaluable subjects.
- In the U.S., the company is currently in discussions with the FDA on the design of the final Phase 3 protocol.
- Price Action: EDSA shares are up 2.75% at $5.83 during the market session on the last check Thursday.
