TORONTO, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the fiscal year ended September 30, 2025 and provided an update on its business. During the year, the company initiated manufacturing activities for a Phase 2 study of Edesa’s dermatology drug candidate, EB06 (an anti-CXCL10 monoclonal antibody), in patients with moderat ...

Core Insights - Edesa Biotech, Inc. announced positive results from a Phase 3 study of paridiprubart (EB05) for treating Acute Respiratory Distress Syndrome (ARDS), showing significant improvements in mortality and clinical outcomes [1][2][5] Study Results - Paridiprubart met both primary and secondary endpoints with statistical significance, demonstrating a 39% risk of death at 28 days compared to 52% for placebo, indicating a 13% absolute improvement in survival [3][10] - At 60 days, the risk of death was 46% for paridiprubart versus 59% for placebo, also reflecting a 13% absolute improvement and a 22% relative risk reduction [3][10] - Patients receiving paridiprubart showed a 41% higher relative rate of clinical improvement, meaning they no longer required invasive mechanical ventilation or organ support by Day 28 [3][8] Safety Profile - The safety population included over 275 subjects, and paridiprubart was generally well-tolerated, consistent with its previously observed safety profile [4][5] Patient Demographics - The study enrolled patients aged 18 and older from 38 hospitals across the USA, Canada, and Colombia, with similar demographics in both treatment and placebo groups [7][8] Mechanism of Action - Paridiprubart is a host-directed therapeutic designed to modulate the immune response against various health threats, inhibiting toll-like receptor 4 (TLR4) [14] Company Overview - Edesa Biotech focuses on developing innovative treatments for inflammatory and immune-related diseases, with a clinical pipeline that includes paridiprubart for ARDS and other therapeutic areas [16][17]