Edesa Biotech, FDA agree on primary endpoint for Phase 3 ARDS drug study

Edesa Biotech reported that the company and the U.S. Food and Drug Administration have agreed on the primary endpoint and population for a pivotal Phase 3 study evaluating Edesa’s monoclonal antibody candidate, EB05, as a therapy for hospitalized patients with a severe form of respiratory failure. The FDA recently granted the program Fast Track designation. Edesa believes that its investigational drug regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome, a severe respiratory illness that can result in long ICU stays and high mortality rates. The agreement announced today follows favorable Phase 2 results, which demonstrated compelling 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 an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days. Under the amended protocol design, Edesa will evaluate a single cohort of severely ill patients on invasive mechanical ventilation, both with and without additional organ support such as extracorporeal membrane oxygenation. Edesa plans to enroll approximately 600 evaluable hospitalized subjects. The primary endpoint will be the mortality rate at 28 days. The number of ventilator free days at 28 days and mortality at 60 days will also be measured as key secondary endpoints. Dr. Nijhawan said that the amended U.S. protocol has been approved by the study’s independent ethics committee. The company reported that recruitment at U.S. hospital sites has been initiated and will scale up in the upcoming quarters as investigational sites complete training on the amended protocol.