Edesa Biotech, Inc. a clinical-stage biopharmaceutical company, has received clearance from the U.S. Food and Drug Administration (FDA) to begin the Phase 2 portion of its Phase 2/3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients. The Phase 2/3 study protocol has previously been approved by Health Canada. The company has begun the site initiation process at U.S. hospitals.
Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the company is committed to rapidly getting EB05 into the hands of physicians on the front line of the pandemic. “Our EB05 study has been deemed safe to proceed by the FDA, marking another milestone in our plans to begin patient enrollment. We believe our drug candidate has the potential to inhibit a key proinflammatory pathway linked to some of the worst effects of the disease.”
EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS) – 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-CoV1 and Influenza viruses. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of ICU patients and intubation/ventilation procedures, and ultimately saving lives.
As planned, Edesa’s Phase 2/3 study will be an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized patients who have or are at risk of developing ARDS. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.