Edesa Biotech Reports Favorable Mortality Reductions in Covid-19 Study
October 19, 2021 at 08:03 am EDT
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Edesa Biotech, Inc. 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 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 + SOC had a 66.0% reduction in the risk of dying when compared to placebo + SOC at 28 days (HR: 2.94 placebo vs. EB05; 95% CI: 0.59-14.60; p=0.19).
Edesa Biotech, Inc. is a Canada-based clinical-stage biopharmaceutical company developing various ways to treat inflammatory and immune-related diseases. The Companyâs advanced drug candidate is EB05 (paridiprubart), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. It is evaluating EB05 in a Phase III study as a potential treatment for acute respiratory distress syndrome (ARDS), a life-threatening form of respiratory failure. In addition, the Company is developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic allergic contact dermatitis (ACD), a common occupational skin condition. It is conducting a Phase II trial of its EB06 monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. The Company is also developing product candidates for a number of chronic dermatological and inflammatory conditions.