Edesa Biotech, Inc. reported that the company has received approval from Health Canada to test its monoclonal antibody candidate, designated EB05, as a rescue therapy for critically ill patients in the Phase 3 part of a Phase 2/3 clinical study. Edesa believes that EB05 regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure that accounts for ~10% of all ICU admissions (pre-pandemic) and is the leading cause of death among COVID-19 patients. Approval of the company's 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.

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 when compared to placebo plus standard of care at 28 days. Edesa reported that the Phase 3 double-blind 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+), defined as Level 7 on the World Health Organization's COVID-19 Severity Scale. The primary endpoint for the Level 7 patients 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. The company has opened patient enrollment under the amended protocol.

Edesa has filed similar protocol amendments with the U.S. Food and Drug Administration as well as other jurisdictions. In the U.S., the company is currently in discussions with the FDA on the design of the final Phase 3 protocol.