Edesa Biotech Inc (NASDAQ:EDSA) shares jumped 77% on Tuesday following the release of supplemental data from a Phase 3 study of paridiprubart, the company’s anti-TLR4 antibody. The updated results, which broaden the evaluated patient population, report statistically significant decreases in adjusted 28-day mortality.
The expanded analysis includes a total of 278 patients. That group comprises 104 patients previously reported who required invasive mechanical ventilation (IMV) and 174 patients who did not require IMV. Across the combined cohort, paridiprubart plus standard of care lowered adjusted 28-day mortality to 24% from 33%, a 27% relative reduction in the risk of death.
In a focused, exploratory assessment of the 174 patients who were not on invasive mechanical ventilation at baseline, the treatment plus standard of care reduced adjusted 28-day mortality to 15% from 23%, corresponding to a 35% relative reduction in the risk of death.
The company reported mortality reductions in several high-risk subgroups. For patients with acute kidney injury, paridiprubart produced a 35% relative reduction in mortality. Among patients diagnosed with sepsis, the treatment achieved a 36% relative reduction. Patients with pneumonia experienced a 30% relative reduction in mortality.
Safety observations were consistent with prior clinical exposure. More than 400 patients have now received paridiprubart, and overall rates of adverse events, serious adverse events, infections and treatment discontinuations were described as low and similar between the treatment and comparator groups.
Following the results, Edesa filed provisional patent applications with the United States Patent and Trademark Office for the use of paridiprubart in treating sepsis, acute kidney injury and pneumonia. The company noted that its core composition-of-matter patents extend into the 2030s.
Edesa said it is continuing regulatory discussions and is evaluating strategic collaborations to support late-stage development and eventual commercialization. The company is also planning manufacturing scale-up. The findings are scheduled to be presented at the American Thoracic Society 2026 International Conference, set for May 15-20, 2026.
Separately, paridiprubart is being tested in a U.S. government-funded study of patients with acute respiratory distress syndrome (ARDS). Enrollment in that trial is ongoing for up to approximately 200 subjects.
Context and next steps
The disclosed dataset expands the population showing benefit in the Phase 3 program and underpins Edesa’s patent filings and planning for regulatory engagement, manufacturing scale-up and potential collaborative deals to support later-stage development and commercialization. Presentation to a scientific audience is scheduled for the American Thoracic Society 2026 meeting.