Edesa Biotech, Inc. (EDSA)

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Edesa Biotech Reports Enrollment Milestone in Phase 3 ARDS Study

TORONTO, ON / ACCESSWIRE / February 17, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today provided an update on the Phase 3 part of a Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate, designated EB05, as a single-dose therapy for hospitalized Covid-19 patients.

Edesa reported that more than 25% of the subjects have been randomized to date under the Phase 3 protocol design approved by Health Canada. The enrollment milestone follows favorable Phase 2 results, which demonstrated compelling preliminary evidence of EB05's ability to reduce mortality in the sickest patients. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, said that as SARS-CoV2 continues to evolve and becomes endemic there's an urgent need for therapeutics, like EB05, that are agnostic to variants. "Since EB05 is designed to target the patient's own immune response rather than the virus itself, we believe it has broad potential application for Covid and beyond," he said.

"We greatly appreciate the extraordinary efforts of the clinical teams and research staff who have been supporting the EB05 study," said Dr. Nijhawan. "Based on the significant effect demonstrated in reducing mortality in the Phase 2 study, we believe that Edesa's monoclonal antibody EB05 could significantly reduce mortalities and alleviate the stress on the healthcare system, especially in the ICU where beds are limited, care is very expensive and patient outcomes have been tragically poor."

EB05 was developed to regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure that accounts for ~10% of all ICU admissions (pre-pandemic) and is the leading cause of death among Covid-19 patients. Specifically, EB05 inhibits toll-like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. In September 2021, the company reported that an independent monitoring board for the Phase 2/3 study concluded that "a clinically important efficacy signal" was detected. The monitoring board further recommended continuation of the study into a Phase 3 confirmatory trial. Edesa's Phase 2 study of EB05 in hospitalized Covid-19 patients was funded in part by a C$14 million grant from the Canadian Government's Strategic Innovation Fund.

The Phase 3 double-blind study is designed to assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus organ support (IMV+), defined as Level 7 on the World Health Organization's COVID-19 Severity Scale. The primary endpoint for the Level 7 patients will be 28-day mortality. Ventilator free days and 60-day mortality will also be measured among other secondary endpoints. The amended trial protocol design calls for approximately 315 evaluable subjects. Edesa has filed similar protocol amendments with the U.S. Food and Drug Administration (FDA) as well as other jurisdictions. In the U.S., the company is currently in discussions with the FDA on the design of the final Phase 3 protocol.

About ARDS
Acute Respiratory Distress Syndrome is the leading cause of death in Covid-19 patients. The U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized Covid-19 patients develop ARDS, which increases to 67% to 85% for patients admitted to the ICU. Mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and characteristics of patient population, according to the CDC. ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

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