Edesa Biotech stock soars on positive Phase 3 clinical trial data

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Investing.com – Edesa Biotech Inc (NASDAQ:EDSA) stock surged 77% on Tuesday after the company announced positive additional data from the Phase 3 study of paridiprubart, showing a statistically significant reduction in mortality across a broader patient population.

The study included 278 patients, including 104 patients who required invasive mechanical ventilation and 174 who did not. The company’s anti-TLR4 antibody reduced the adjusted 28-day mortality from 33% to 24%, a 27% relative reduction in risk of death.

In an exploratory analysis of the 174 non-invasive mechanical ventilation patients, paridiprubart combined with standard treatment lowered the adjusted 28-day mortality from 23% to 15%, a 35% relative reduction in risk.

The treatment also showed a reduction in mortality among patients with severe comorbidities. In patients with acute kidney injury, paridiprubart reduced mortality by 35% relative. For sepsis patients, the reduction was 36%, and for pneumonia patients, 30%.

Safety features were consistent with previous clinical exposure, with over 400 patients treated with paridiprubart. The overall incidence of adverse events, serious adverse events, infections, and treatment discontinuations was low and similar across treatment groups.

Based on these results, Edesa has filed a provisional patent application with the U.S. Patent and Trademark Office covering the use of paridiprubart in treating sepsis, acute kidney injury, and pneumonia. The company’s core composition patent will extend into the 2030s.

Edesa is advancing regulatory discussions and evaluating strategic partnerships to support late-stage development and commercialization. The company is also planning manufacturing scale-up and will present the study results at the American Thoracic Society’s 2026 International Conference scheduled for May 15-20, 2026.

Paridiprubart is currently being evaluated in an independent, government-funded study for patients with acute respiratory distress syndrome, recruiting approximately 200 participants.

This article was translated with the assistance of artificial intelligence. For more information, please see our Terms of Use.

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