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Sept. 30, 2022, 8:16 a.m. EDT

Edesa Biotech Reports Statistically Significant Mortality Reductions in Phase 2 ARDS Drug Study

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  • Mortality reduction in critically ill subjects at 28 days revised favorably, statistically significant

  • EB05 demonstrated an 84% reduction in the risk of dying when compared to placebo

  • Clinical Study Report submitted to FDA

TORONTO, ON / ACCESSWIRE / September 30, 2022 / Edesa Biotech, Inc. /zigman2/quotes/200172674/composite EDSA +0.62% , a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced final results from the Phase 2 portion of its ongoing Phase 2/Phase 3 clinical study. The study is evaluating the company's monoclonal antibody candidate, EB05, as a single-dose treatment for hospitalized patients with or at risk of developing Covid-19 induced Acute Respiratory Distress Syndrome (ARDS). The company previously reported initial topline data provided by the study's data safety monitoring board, which preemptively unblinded certain study data for efficacy signals. Edesa has now completed a formal Clinical Study Report (CSR) for U.S. regulators on the full, validated Phase 2 dataset.

In the final Phase 2 clinical trial results, Edesa reported that EB05 demonstrated a statistically significant and clinically meaningful trend for mortality and survival time for all randomized subjects in the critically ill cohort (the intent to treat, or ITT, population). Today, the company reported a revised 28-day death rate of 7.7% in the EB05 plus standard of care (SOC) arm versus 40% in the placebo + SOC arm in critically severe patients on ECMO therapy (extracorporeal membrane oxygenation) or Invasive Mechanical Ventilation (IMV) plus organ support with ARDS at baseline (p=0.04). The revised Survival Analysis using Cox's Proportional Hazard Model demonstrated that patients treated with EB05 plus SOC had an 84.0% reduction in the risk of dying when compared to placebo + SOC at 28 days.

"Achieving statistical significance within one of the most difficult to treat subgroups of patients with Covid-induced ARDS has increased our excitement and belief that EB05 could become a standard-of-care treatment option," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "These validated data along with additional efficacy signals observed strengthen the previously released results and suggests that the utility of EB05 may be more significant and wide-ranging than the initial topline data indicated."

Dr. Nijhawan noted that since EB05 is designed to target the patient's own immune response rather than the virus itself, the investigation therapy could potentially have broad application across multiple disease indications, including ARDS caused by influenza and other potentially deadly pathogens. "There is a significant unmet medical need for critically ill ARDS patients caused by seasonal influenza and pneumonia that's made considerably worse by the endemic nature of Covid-19, and we believe that EB05 can help address this problem," he said.

The company submitted the Phase 2 CSR this week to the U.S. Food and Drug Administration as part of the review of Edesa's Phase 3 clinical protocol design and statistical plan. The Phase 3 study design has already been approved in Canada, Colombia and Poland, where recruitment is ongoing.

Edesa's Phase 2 study of EB05 was funded in part by a C$14 million grant from the Canadian Government's Strategic Innovation Fund.

Additional Phase 2 Results

Study Design

The Phase 2 part of the Phase 2/3 study was primarily exploratory and designed to refine patient stratification and statistical powering for the Phase 3 study. All levels of hospitalized Covid-19 patients were enrolled, ranging from Level 3 (hospitalized, not requiring supplemental oxygen) on the nine-point WHO Covid-19 Severity Scale (WCSS) to WCSS Level 7 (hospitalized, requiring intubation plus additional organ support such as ECMO). Enrollment in the study as well as the analysis was stratified according to baseline WCSS level into patients with mild Covid-19, defined as WCSS level ≤4, or severe Covid-19, defined as WCSS level ≥5.

Additional Results

In addition to the critically ill population, the analysis of the full Phase 2 dataset revealed other efficacy signals.

For severe Covid-19 patients at WCSS Level ≥5 (99% of patients had ARDS at baseline), there were clinically meaningful differences with respect to the proportion of patients who were alive without any need for oxygen support at Day 28 (the Phase 2 study's primary endpoint). From the ITT analysis of this population, 45.8% in the EB05 + SOC arm versus 36.1% in the placebo + SOC arm achieved the primary endpoint (p = 0.16).

Similarly positive efficacy signals were also demonstrated in this same population for the proportion of patients who achieved at least a 2-point improvement in on the WCSS. From the ITT analysis of this population, 46.7% in the EB05 + SOC arm versus 36.1% in the placebo + SOC arm achieved at least a 2-point improvement in on the WCSS (p = 0.12).

For mild Covid-19 patients at WCSS Level ≤4, the study did not detect meaningful clinical differences between the arms for these endpoints, which is likely the result of the baseline severity score being too close to the endpoint (WCSS of 3 or less) on these scoring scales.

The Phase 2 results demonstrated that EB05 was generally well-tolerated and consistent with the observed safety profile to date. Serious adverse events from 352 subjects showed comparable results between treatment groups. Incidence of Treatment Emergent Adverse Events (TEAEs) and serious TEAEs were similar across the treatment groups.

Summary of Key Clinical Results

The following tables summarize the key signals detected in the Phase 2 study.

Mortality Rates - Critically Ill Patients (WCSS Level 7)

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