Edesa Biotech and FDA Agree on Primary Endpoint for Phase 3 ARDS Drug Study

• 28-day survival will be evaluated in ARDS patients hospitalized with Covid-19
• Updated protocol approved by study's ethics committee
• Company exploring pathways for treating general ARDS patients

Edesa Biotech, Inc. (EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported that the company and the U.S. Food and Drug Administration (FDA) have agreed on the primary endpoint and population for a pivotal Phase 3 study evaluating Edesa's monoclonal antibody candidate, EB05, as a therapy for hospitalized patients with a severe form of respiratory failure. The FDA recently granted the program Fast Track designation.

Edesa believes that its investigational drug regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS), a severe respiratory illness that can result in long ICU stays and high mortality rates. The agreement announced today follows favorable Phase 2 results, which demonstrated compelling 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 an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Under the amended protocol design, Edesa will evaluate a single cohort of severely ill patients on invasive mechanical ventilation, both with and without additional organ support such as extracorporeal membrane oxygenation (ECMO). Edesa plans to enroll approximately 600 evaluable hospitalized subjects. The primary endpoint will be the mortality rate at 28 days. The number of ventilator free days at 28 days and mortality at 60 days will also be measured as key secondary endpoints.

"We are pleased with the outcome of our discussions with the FDA. Based on the strength of the preliminary data submitted, the FDA proposed using a 28-day mortality endpoint for the Phase 3 study," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "This was our preferred efficacy endpoint and a significant milestone in the development of our lead product candidate. We are now one significant step closer to completing our study and providing effective treatment options for severely ill patients."

Dr. Nijhawan said that the amended U.S. protocol has been approved by the study's independent ethics committee (formally known as the Institutional Review Board, or IRB). The company reported that recruitment at U.S. hospital sites has been initiated and will scale up in the upcoming quarters as investigational sites complete training on the amended protocol.

"This amended protocol provides an efficient design to facilitate recruitment and a clearer pathway to conducting a study in general ARDS since the updated protocol is not tied directly to treatment modalities defined by the World Health Organization Covid-19 Severity Scale," said Dr. Nijhawan.

He noted that since EB05 is designed to target the patient's own immune response (independent of the infectious agent), the investigational therapy could potentially have broad application across multiple disease indications, including ARDS caused by influenza and other potentially deadly pathogens. The company is currently exploring various approaches to evaluating EB05 in a general ARDS population.