EDSA - Edesa nabs regulatory nod for sub set of phase2/3 EB05 COVID-19 study

Clinical-stage biopharma Edesa Biotech (EDSA) gets regulatory approval from the U.S. FDA and Health Canada to add a sub-study to its ongoing Phase 2/3 study of its investigational drug, EB05, for the treatment of Acute Respiratory Distress Syndrome ((ARDS)) - the leading cause of death in COVID-19 patients.The sub-study will evaluate the drug as a potential rescue therapy for critically severe COVID-19 cases, and is expected to enroll up to 100 ICU patients with severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation ((ECMO)) therapy.Edesa's Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05.EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with ARDS.

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Edesa nabs regulatory nod for sub set of phase2/3 EB05 COVID-19 study