Edesa Biotech announces Health Canada approval of updated trial design

Edesa Biotech announced that Health Canada has approved the company’s proposal to harmonize clinical trial designs in the U.S. and Canada for an ongoing Phase 3 study of EB05. Edesa’s monoclonal antibody is currently being evaluated as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure characterized by widespread inflammatory injury to the lungs. Approximately 10% of all ICU admissions are ARDS related. The harmonized protocol calls for treatment of approximately 600 ARDS subjects hospitalized with SARS-CoV2 infections who are on invasive mechanical ventilation, both with and without additional organ support such as extracorporeal membrane oxygenation. The primary endpoint is the mortality rate at 28 days. The amended study design replaces the previous protocol which targeted a population of more than 800 subjects, with two independent cohorts and cohort-specific endpoints. Earlier this year, Edesa and the U.S. Food and Drug Administration agreed on the primary efficacy endpoint and single, smaller population for the Phase 3 study. Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech said that having a single, harmonized protocol in the U.S. and Canada will facilitate enrollment, trial management and data analysis. Paridiprubart is a first-in-class monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. This host-directed therapeutic candidate inhibits toll-like receptor 4, a key immune signaling protein that has been shown to be activated both by viruses, like SARS-CoV2 and influenza, as well as in the pathogenesis of chronic autoimmune diseases. In a Phase 2 clinical study that the company completed during the pandemic EB05 reduced mortality by 84% among critically ill patients with ARDS. A parallel in vitro study also demonstrated that paridiprubart inhibits inflammation from influenza and other pathogens. Nijhawan said that the company is also exploring various approaches to evaluate EB05 in a general, all-cause ARDS population.