- Edesa Biotech Inc (NASDAQ:EDSA) has initiated enrollment for the second cohort of patients for the Phase 3 part of a Phase 2/3 study of the company's critical care drug candidate, designated EB05.
- Edesa is currently evaluating EB05, a monoclonal antibody, in critically ill patients with COVID-19-induced Acute Respiratory Distress Syndrome (ARDS).
- The company's first study cohort is recruiting the most critically severe patients receiving mechanical ventilation plus additional organ support (Level 7).
- This new second cohort is open to hospitalized patients on invasive mechanical ventilation alone (Level 6). Edesa's decision to include the second cohort followed a company review of drug product inventories of EB05.
- Related: Canada Approves Edesa Biotech's COVID-19 Trial For EB05 Antibody As Rescue Therapy.
- The primary endpoint for the Level 6 patients will be the number of ventilator-free days at Day 28 following administration of a single intravenous infusion of EB05.
- Secondary endpoints will include ventilator-free days at Day 60 and the mortality rate at Day 28 and Day 60.
- The protocol for the Level 6 cohort calls for approximately 500 evaluable subjects, with approximately 315 evaluable subjects for the Level 7 patients.
- Price Action: EDSA shares are down 3.21% at $1.81 during the market session on the last check Tuesday.
