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

Jan. 13, 2022 8:57 AM ETEdesa Biotech, Inc. (EDSA)By: Mamta Mayani, SA News Editor

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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.
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