Edesa Biotech, Inc. (EDSA)

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Edesa Biotech Gets Approval to Add Sub-Study for Covid-19 Treatment
8:02 am ET January 26, 2021 (Dow Jones) Print

By Chris Wack


Edesa Biotech Inc. said Tuesday it has received regulatory approval from the U.S. Food and Drug Administration and Health Canada to add a sub-study to its Phase 2/Phase 3 clinical trial of its investigational drug, EB05, for the treatment of Acute Respiratory Distress Syndrome.

The biopharmaceutical comapny said the sub-study would evaluate the drug as a potential rescue therapy for critically severe Covid-19 cases.

Edesa's sub-study is expected to enroll up to 100 intensive-care patients with severe Covid-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation therapy. The sub-study doesn't affect the design or results of Edesa's international Phase 2/3 study.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with ARDS. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to intensive care units and intubation/ventilation procedures, and ultimately saving lives. Up to 316 patients will be enrolled in the Phase 2 part of the trial in Canada, the U.S. and Colombia. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.

Edesa Biotech shares were up 80% to $9.89 in premarket trading.