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Edesa Biotech Extends COVID-19 Clinical Study to Poland
Expansion to European Union country follows favorable Phase 2 resultsCompany focusing on critically ill hospitalized patientsTORONTO, ON / ACCESSWIRE /
About this update from Edesa Biotech, Inc.
[{"type":"text","content":"Expansion to European Union country follows favorable Phase 2 resultsCompany focusing on critically ill hospitalized patientsTORONTO, ON / ACCESSWIRE / November 4, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that Polish regulators have approved a clinical trial application for the investigational use of the company's monoclonal antibody candidate, designated EB05, as a single-dose treatment for hospitalized COVID-19 patients. Enrollment in the Phase 2/3 drug trial is ongoing in the U.S., Canada and Colombia.Edesa believes that EB05 could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients. The company recently reported that critically ill hospitalized patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.Due to the lack of treatments available to patients with severe respiratory distress, the company has reported that it will focus enrollment for the Phase 3 portion of its international study on patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation (IMV) plus organ support.\"We urgently need effective therapies for patients once they become hospitalized, especially for ARDS patients who have failed all other drugs and treatment modalities. Given the profound effect that EB05 has demonstrated in reducing death in the most critically ill patient population, we are looking forward to expanding the study to Poland where daily COVID-19 case counts are high and on the rise,\" said Par Nijhawan, MD, Chief Executive Officer of Edesa.Dr. Nijhawan reported that Edesa has enlisted the support of a local research organization and will begin activating hospital sites in major metropolitan areas.Edesa's international Phase 2/3 study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. The company is currently filing amendments with regulators in the United States, Canada and Colombia to update the Phase 3 protocol based on Phase 2 results, and set targeted enrollment. Edesa is al...