Edesa Biotech gets green light for COVID-19 monoclonal antibody study in the US
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. Edesa Biotech hopes the treatment could reduce the number of patients on ventilators and ultimately save lives.
Green light for studies in US and Canada
Edesa Biotech’s pipeline includes two monoclonal antibodies: EB05 (targeting TLR4) and EB06 (targeting the chemokine CXCL10). Edesa Biotech is prioritizing the evaluation of these as potential treatments for moderate to severe cases of COVID-19.
Prior to COVID-19, ARDS accounted for 10% of intensive care unit admissions. COVID-19 can cause severe acute respiratory failure in up to 40% of hospitalized COVID-19 patients and up to 85% of patients admitted to intensive care.
In June, the Ontario, Canada headquartered biotech received expedited approval from Health Canada to begin the Phase 2/3 clinical study for EB05. This has been followed this week by the green light from the FDA in the US.
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.
Dr. Par Nijhawan, Chief Executive Officer of Edesa, said: "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 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.