Edesa Biotech, Inc. Completes Enrollment of More Than 50% of the Patients Planned for the Phase 2 Portion of Its Ongoing Phase 2/Phase 3 Clinical Study
March 15, 2021 at 08:12 am EDT
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Edesa Biotech, Inc. announced that it has completed enrollment of more than 50% of the patients planned for the Phase 2 portion of its ongoing Phase 2/Phase 3 clinical study evaluating the company's EB05 drug candidate as a single-dose treatment for hospitalized COVID-19 patients with or at risk of developing Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients. The company reported that more than 160 of the expected 316 subjects in the Phase 2 portion of the study have been randomized and dosed with either EB05 or placebo. The patients were treated at hospital sites across Canada, the United States and Colombia. In preparation for the potential Phase 3 portion of the study, the company plans to activate approximately 20 additional hospital sites in the next two months. Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa reported that the company plans to continue adding hospital sites to speed enrollment and to provide broad access to a promising experimental therapy. As designed, the international study is an adaptive, double-blind study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Should the experimental antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study. EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with ARDS. 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.
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.
Edesa Biotech, Inc. Completes Enrollment of More Than 50% of the Patients Planned for the Phase 2 Portion of Its Ongoing Phase 2/Phase 3 Clinical Study