Benzinga | Jun 18, 2021 07:47AM EDT

Edesa Biotech Announces An Independent Data And Safety Monitoring Board Has Completed Interim Review Of Co.'s COVID-19 Candidate And Recommended Study Continue As Planned

Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported that an independent Data and Safety Monitoring Board (DSMB) has completed an interim review of the company's COVID-19 drug candidate, and based on blinded comparative data, has recommended that the company's international study continue as planned.

The safety monitoring board, composed of independent subject matter experts, conducted a pre-planned interim review of the first patient cohort participating in Edesa's Phase 2/3 clinical study evaluating the company's EB05 drug candidate as a single-dose treatment for hospitalized COVID-19 patients. The DSMB assessed treatment data for safety and futility. After completing their analysis, the DSMB recommended that enrollment in the trial continue.

"The DSMB's recommendation that the trial continue is consistent with our expectation and the previous safety and tolerability profile of EB05," said Dr. Par Nijhawan, Chief Executive Officer of Edesa. "While it is not possible yet to draw conclusions, we are encouraged by the monitoring board's findings as well as the robust enrollment we have achieved to date."

Dr. Nijhawan said that Edesa is evaluating opportunities to expedite the timeline for completing the remaining part of the study and building a single robust dataset. As of June 16, 2021, more than 370 subjects in the U.S., Canada and Colombia have been enrolled in the Phase 2/3 study. The company plans to perform the next interim analysis on 316 evaluable subjects once treatment is completed and subject data is validated and aggregated.

The company recently filed a trial amendment with the Food and Drug Administration to streamline the U.S. protocol and align it with other jurisdictions. Following the exploratory analysis, the company also plans to adjust its current patient segmentation and associated endpoints, and maintain blinded data through the end of Phase 3.

"These planned changes could significantly reduce the number of additional patients enrolled in the study and could put us in the position to demonstrate results sooner," said Blair Gordon, PhD, Edesa Vice President of Research and Development.

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. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to Intensive Care Units (ICU) and intubation/ventilation procedures, and ultimately saving lives.

JSS Medical Research is acting as Edesa's contract research organization for the international Phase 2/3 study. Hospitals and physicians interested in participating in the Phase 2/3 study of EB05 should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475).