Edesa Biotech reported that its anti‑TLR4 antibody paridiprubart achieved additional positive results in a 278‑patient Phase 3 study for acute respiratory distress syndrome (ARDS). The expanded analysis confirmed a statistically significant 28‑day mortality reduction, with adjusted mortality falling to 24% versus 33% in the placebo group, a 27% relative risk reduction (p < 0.001).
The study also demonstrated consistent benefit across severity groups, including a 35% relative mortality reduction in the 174‑patient non‑invasive ventilation subgroup (15% versus 23% mortality, p < 0.05). Safety data remained favorable, with low rates of serious adverse events, infections, and treatment discontinuations comparable to placebo.
Edesa’s leadership highlighted that the new data reinforce the therapeutic potential of paridiprubart across multiple high‑mortality ARDS etiologies and support ongoing regulatory discussions and partnership negotiations aimed at accelerating development and global access. CEO Par Nijhawan said, "the results announced today align with the central role of TLR4 in hyperinflammatory ARDS and demonstrate consistent benefit across high‑mortality etiologies."
More than 400 patients have now received paridiprubart, and the company has filed provisional U.S. patents for its use in sepsis, acute kidney injury and pneumonia, positioning the antibody for a broader therapeutic portfolio.
Edesa Biotech is a clinical‑stage biopharmaceutical company with no current revenue and a net loss of $2.2 million for the three months ended December 31 2025. The company maintains a strong current ratio of 16.82 and holds more cash than debt, providing a substantial runway for continued development, although investors have mixed views on the company’s long‑term prospects.
Paridiprubart is a first‑in‑class anti‑TLR4 antibody that blocks receptor dimerization and downstream inflammatory signaling. The company is supported by government funding from Canada and a U.S. government‑funded study, and it has increased its at‑the‑market offering limit to secure additional financing. Edesa will present further Phase 3 findings at the American Thoracic Society 2026 International Conference (May 15‑20).
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