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Edesa Biotech Announces Positive Phase 2 Data of Its Monoclonal Antibody in Hospitalized COVID-19 Patients
Study unblinded due to strong efficacy signal for 28-day mortality endpointCritically ill patients demonstrated a 68.5% reduction in the risk of dying when
About this update from Edesa Biotech, Inc.
[{"type":"text","content":"Study unblinded due to strong efficacy signal for 28-day mortality endpointCritically ill patients demonstrated a 68.5% reduction in the risk of dying when treated with EB05 over Standard of CareData monitoring board recommends continuation to confirmatory Phase 3 studyTORONTO, ON / ACCESSWIRE / September 20, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced positive results from the Phase 2 part of an ongoing Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate, designated EB05, 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 28-day death rate of 14.3% (2/14) in the EB05 arm versus 36.8% (7/19) in the placebo arm in critically severe patients on ECMO therapy (extracorporeal membrane oxygenation). Survival Analysis using Cox's Proportional Hazard Model showed that the patients treated with EB05 plus standard of care had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days (HR: 3.17 placebo vs. EB05; 95% CI: 0.66-15.35; p=0.15). The currently available data indicates that greater than 90% of patients received dexamethasone (or other steroids), more than 45% received both tocilizumab and a steroid.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.Dr. Par Nijhawan, MD, Chief ...