Edesa Biotech secures Canadian approval to test COVID-19 drug as rescue therapy

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• Edesa Biotech (NASDAQ:EDSA) has received approval from Health Canada to test its monoclonal antibody candidate, designated EB05, as a rescue therapy for critically ill patients in Phase 3 part of a Phase 2/3 clinical study.
• The Phase 3 study is designed to assess the efficacy and safety of EB05 among critically ill COVID-19 patients. The primary endpoint will be 28-day mortality. Ventilator free days and 60-day mortality will also be measured among other secondary endpoints.
• The amended trial protocol design calls for approximately 315 evaluable subjects.
• Approval of the Phase 3 study design follows favorable Phase 2 results, which demonstrated compelling preliminary evidence of EB05's ability to reduce mortality in the sickest patients.