Edesa Biotech receives Fast Track designation for EB05

Edesa Biotech has received Fast Track designation from the U.S. Food and Drug Administration for its monoclonal antibody candidate, EB05. Approval of the company’s application follows favorable Phase 2 results from an international Phase 2/3 study of EB05 in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome, a severe form of respiratory failure characterized by widespread inflammatory injury to the lungs. Edesa recently reported that Phase 2 results offered statistically significant evidence of EB05’s ability to reduce death in the most critically ill hospitalized Covid-19 patients. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.