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Wednesday, October 25, 2023

Regulators Approve Updated Phase 3 Trial Design for Edesa Biotech’s ARDS Drug

 Edesa Biotech, Inc.  (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that Health Canada has approved the company's proposal to harmonize clinical trial designs in the U.S. and Canada for an ongoing Phase 3 study of EB05 (paridiprubart). Edesa's monoclonal antibody is currently being evaluated as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure characterized by widespread inflammatory injury to the lungs. Approximately 10% of all ICU admissions are ARDS related.

https://www.biospace.com/article/releases/regulators-approve-updated-phase-3-trial-design-for-edesa-biotech-s-ards-drug/

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