On February 24, 2026, Edesa Biotech, Inc. (EDSA) announced additional positive data from the company's Phase 3 study of EB05 (paridiprubart) in acute respiratory distress syndrome (ARDS), which expanded upon the October 2025 findings with data from the full 278-patient safety population. The updated analysis confirmed a statistically significant reduction in 28-day mortality and improved clinical recovery compared with standard of care alone. These results reinforce the earlier survival benefit seen in mechanically ventilated patients and position paridiprubart as a potential first-in-class host-directed therapy in a disease with no approved drug treatments. Edesa plans to engage U.S. and Canadian regulators to determine the optimal path forward, including the possibility of accelerated approval, while an on-going ~200-patient BARDA-funded study continues to generate supportive data.
02 Mar 2026
EDSA: Strengthened Phase 3 ARDS Data Shows Significant Reduction in 28-Day Mortality
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EDSA: Strengthened Phase 3 ARDS Data Shows Significant Reduction in 28-Day Mortality
- Published:
02 Mar 2026 -
Author:
David Bautz -
Pages:
8 -
On February 24, 2026, Edesa Biotech, Inc. (EDSA) announced additional positive data from the company's Phase 3 study of EB05 (paridiprubart) in acute respiratory distress syndrome (ARDS), which expanded upon the October 2025 findings with data from the full 278-patient safety population. The updated analysis confirmed a statistically significant reduction in 28-day mortality and improved clinical recovery compared with standard of care alone. These results reinforce the earlier survival benefit seen in mechanically ventilated patients and position paridiprubart as a potential first-in-class host-directed therapy in a disease with no approved drug treatments. Edesa plans to engage U.S. and Canadian regulators to determine the optimal path forward, including the possibility of accelerated approval, while an on-going ~200-patient BARDA-funded study continues to generate supportive data.