Benzinga | Jan 13, 2022 11:47AM EST

Edesa Biotech Receives Canadian Approval To Test COVID-19 Drug As Rescue Therapy

Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported that the company has received approval from Health Canada to test its monoclonal antibody candidate, designated EB05, as a rescue therapy for critically ill patients in the Phase 3 part of a Phase 2/3 clinical study.

Edesa believes that EB05 regulates 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. Approval of the company's Phase 3 study design 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.

"Health Canada's approval represents a significant milestone in our goal of demonstrating the broad potential utility of EB05 in a critical care setting," said Par Nijhawan, MD, Chief Executive Officer of Edesa. He noted that there's an urgent need for therapeutics that are agnostic to SARS-CoV2 variants.

"The growing number of COVID variants - and the inherent limits of vaccines and anti-viral drugs - have highlighted the importance of agnostic therapies, like EB05, that target the patient's immune response rather than the virus. While the Phase 3 study is designed to confirm the Phase 2 results, the preliminary data shows that EB05 has already saved lives. Perhaps just as important, this innovative technology is providing greater confidence that COVID can be well managed one day, like other endemic diseases," said Dr. Nijhawan.

Edesa reported that 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. The company has opened patient enrollment under the amended protocol.

Health Canada reviewed Edesa's study design amendment and approved it by issuing a "Notice of Authorization," which allows the company to proceed with its planned study design. Under the amended protocol, Edesa also has the option to complete a separate study group of less severe patients receiving only invasive mechanical ventilation (WHO COVID-19 Severity Scale Level 6), which would be evaluated independently.

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 EB05

EB05 is a monoclonal antibody designed to inhibit 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 and that the Phase 2 study "met its objective." 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.

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.