Edesa Biotech Adds Mechanically Ventilated Patients To Late-Stage COVID-19 Study

Edesa Biotech Inc 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.