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Edesa Biotech Receives Canadian Approval to Test COVID-19 Drug as Rescue Therapy
Phase 3 study will focus on critically ill patients, many of whom have run out of effective drug treatment optionsTORONTO, ON / ACCESSWIRE / January 13, 2022
About this update from Edesa Biotech, Inc.
[{"type":"text","content":"Phase 3 study will focus on critically ill patients, many of whom have run out of effective drug treatment optionsTORONTO, ON / ACCESSWIRE / January 13, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported that the company has received approval from Health Canada to test its monoclonal antibody candidate, designated EB05, as a rescue therapy for critically ill patients in the Phase 3 part of a Phase 2/3 clinical study.Edesa believes that EB05 regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure that accounts for ~10% of all ICU admissions (pre-pandemic) and is the leading cause of death among COVID-19 patients. Approval of the company's Phase 3 study design follows favorable Phase 2 results, which demonstrated compelling preliminary evidence of EB05's ability to reduce mortality in the sickest patients. Among the results, critically ill hospitalized COVID-19 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.\"Health Canada's approval represents a significant milestone in our goal of demonstrating the broad potential utility of EB05 in a critical care setting,\" said Par Nijhawan, MD, Chief Executive Officer of Edesa. He noted that there's an urgent need for therapeutics that are agnostic to SARS-CoV2 variants.\"The growing number of COVID variants - and the inherent limits of vaccines and anti-viral drugs - have highlighted the importance of agnostic therapies, like EB05, that target the patient's immune response rather than the virus. While the Phase 3 study is designed to confirm the Phase 2 results, the preliminary data shows that EB05 has already saved lives. Perhaps just as important, this innovative technology is providing greater confidence that COVID can be well managed one day, like other endemic diseases,\" said Dr. Nijhawan.Edesa reported that the Phase 3 double-blind study is designed to assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus organ support (IMV+), defined as Level 7 on the ...