Benzinga | Aug 26, 2021 07:33AM EDT

Edesa Biotech Says As Of Aug. 25, Over 525 Subjects Have Been Enrolled In EB05 Study

Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today provided an update on a Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate as a single-dose therapy for hospitalized COVID-19 patients.

As of August 25, 2021, Edesa reported that more than 525 subjects have been randomized into the study to be treated with either Edesa's monoclonal antibody (designated EB05) plus standard of care treatment, or placebo plus standard of care. Approximately 35 of these patients have been assigned to an investigation sub-study evaluating EB05 as a rescue therapy for patients with critically severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation (ECMO) therapy.

Additionally, the company reported that all patients planned for a key interim analysis have been randomized and completed the treatment protocol. Edesa expects the analysis from third-party statisticians to be completed in the coming weeks.

The company said that the interim analysis will include data from approximately 316 subjects. The blinded comparative interim analysis of treatment data and events is expected to inform patient segmentation and associated endpoints for the final part of study. As a Phase 2/3 study, enrollment has continued during the analysis.

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, attributed the rapid pace of enrollment to the growing scientific rationale for targeting Toll-like Receptor 4 (TLR4), the attractiveness of the single-dose treatment, the broad potential utility for the drug candidate as well as increased disease incidence in regions where Edesa's clinical sites are located.

"We have continued to see rapid enrollment in our trial this summer, especially in the southern hemisphere. With the Delta variant causing another wave of infections in North America, we are now experiencing some of the highest weekly rates of enrollment since we initiated our study," said Dr. Nijhawan. "The prevalence of the Delta variant, as well as any future variants, underscores the urgent need for therapeutics that can address the mechanisms underlying the progression to severe disease and respiratory failure."

"We anticipate being in a position to provide the interim results for our Phase 2/3 study this quarter," said Dr. Nijhawan. "On behalf of Edesa, I'd like to express our continuing gratitude to the patients, their families and healthcare workers along with the clinical site teams for enabling us to reach these key milestones."

Dr. Blair Gordon, Edesa's Vice President of Research and Development, reported that with support from the federal government, the company has now established a network of 46 clinical sites at hospitals in Canada, Colombia and the United States.

"With all the planned clinical sites trained and up-and-running, and drug product on hand, our research and development team and study partners are preparing for an efficient transition into the anticipated Phase 3 study portion of the study," he said.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS). ARDS is the leading cause of death in COVID-19 patients. Specifically, the drug 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. Prior to COVID-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

Edesa's study of EB05 in hospitalized COVID-19 patients is being funded in part by a C$14 million grant from the Canadian Government. To date, the company has reached all clinical enrollment and project targets specified under the grant ahead of schedule.