Edesa Biotech, Inc. Completes Independent Data and Safety Monitoring Board Interim Review of COVID-19 Drug Candidate
June 18, 2021 at 09:09 am EDT
Share
Edesa Biotech, Inc. 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. 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. 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.
Edesa Biotech, Inc. is a Canada-based clinical-stage biopharmaceutical company developing various ways to treat inflammatory and immune-related diseases. The Companyâs advanced drug candidate is EB05 (paridiprubart), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. It is evaluating EB05 in a Phase III study as a potential treatment for acute respiratory distress syndrome (ARDS), a life-threatening form of respiratory failure. In addition, the Company is developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic allergic contact dermatitis (ACD), a common occupational skin condition. It is conducting a Phase II trial of its EB06 monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. The Company is also developing product candidates for a number of chronic dermatological and inflammatory conditions.