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Edesa Biotech Reports Favorable Mortality Reductions in COVID-19 Study
Mortality reductions demonstrated across multiple patient groupsAdditional efficacy signals recorded in a broad range of mild to severe ARDS patientsCompany
About this update from Edesa Biotech, Inc.
[{"type":"text","content":"Mortality reductions demonstrated across multiple patient groupsAdditional efficacy signals recorded in a broad range of mild to severe ARDS patientsCompany to focus on critically ill population for Phase 3TORONTO, ON / ACCESSWIRE / October 19, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced additional 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.The Phase 2 data were preemptively unblinded last month by the study's Data and Safety Monitoring Board (DSMB) due to a clinically important efficacy signal detected among the most critically ill patients. Since then, the analysis of the results has continued in other patient groups. Edesa believes EB05 regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients.Edesa reported today that EB05 demonstrated mortality reductions in multiple patient groups beyond the initial findings, which showed that critically ill hospitalized patients treated with EB05 + Standard of Care treatment (SOC) had a 68.5% reduction in the risk of dying when compared to placebo + SOC at 28 days. Additional efficacy signals have also been identified.Among the findings, the DSMB noted another mortality benefit in 136 hospitalized COVID-19 patients receiving supplemental oxygen (28-day mortality rate of 8.2% (5/61) in the EB05 + SOC arm versus 12.0% (9/75) in the placebo + SOC arm, Hazard Ratio (HR): 1.52 placebo vs. EB05, n=136). Within this group, a strong signal for patients with severe ARDS at baseline (based on the Berlin score) was investigated by the DSMB and was part of their decision to unblind the study. Consistent with the signal previously reported in critically ill patients, the DSMB concluded that the severe ARDS patients receiving supplemental oxygen at baseline had \"a clinically important efficacy signal\" with a 28-day mortality rate of 16.7% (2/12) in the EB05 + SOC arm versus 42.9% (6/14) in the placebo + SOC arm. Survival Analysis using Cox's Proportional Hazard Model in this group showed that the subjects treated with EB05 + S...