Edesa Biotech, Inc. announced positive results from the Phase 2 part of an ongoing Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate as a single-dose treatment for hospitalized COVID-19 patients. An independent Data and Safety Monitoring Board (DSMB), composed of subject matter experts, informed the company that during its initial analysis of the Phase 2 portion of the study they identified an important signal between the treatment arms for 28-day mortality, and requested that the study be preemptively unblinded. While the Phase 2 portion was primarily designed to refine patient stratification and statistical powering for the Phase 3 study, the DSMB concluded that "a clinically important efficacy signal" was detected and that the study has "met its objective." The DSMB further recommended continuation of the study into a Phase 3 confirmatory trial. Among the findings, the DSMB reported a Cox's Proportional Hazard estimate for death of 14.3% (2/14) in the EB05 arm versus 36.8% (7/19) in the placebo arm, representing a 217% improvement in the relative likelihood of survival (HR: 3.17; 95%CI: 0.66-15.35; p=0.15) in critically severe patients on ECMO therapy (extracorporeal membrane oxygenation) with or without invasive mechanical ventilation, at 28 days versus Standard of Care treatment alone. Approximately 100% of patients received dexamethasone (or other steroids), 60% received tocilizumab, and 60% received both, balanced across both arms of the study. The results from the Phase 2 analysis also suggest that EB05 has been generally well-tolerated and consistent with the observed safety profile to date. In addition, the DSMB identified another patient group with robust signals for mortality reduction at 28 days and the company plans to review this data as well as the full dataset. The analysis reviewed data from approximately 360 patients, 24 to 93 years of age, from investigational sites in the United States, Canada and Colombia. Participants were treated with a single intravenous infusion of either EB05 plus standard of care treatment, or placebo plus standard of care (randomized 1:1). The DSMB's initial analysis was limited to the mortality endpoint, and a review of other endpoints is ongoing.