Edesa Biotech Announces Positive Phase 3 Results for Paridiprubart in ARDS Treatment
Edesa Biotech, Inc. reported positive results from a Phase 3 study of its drug candidate paridiprubart (EB05) for treating Acute Respiratory Distress Syndrome (ARDS). The study met primary and secondary endpoints with statistical significance, showing a clinically meaningful reduction in mortality at 28 and 60 days. Patients treated with paridiprubart plus standard of care had a 39% risk of death at 28 days compared to 52% for placebo, with a 13% absolute improvement in survival. At 60 days, the risk of death was 46% for paridiprubart versus 59% for placebo. The drug also demonstrated a 41% higher relative rate of clinical improvement, reducing the need for invasive mechanical ventilation and organ support. The study involved 104 patients from 38 hospitals in the USA, Canada, and Colombia. Paridiprubart was well-tolerated, with a safety profile consistent with previous observations. The drug is also being evaluated in the U.S. government's 'Just Breathe' study and receives funding from the Government of Canada’s Strategic Innovation Fund.