Edesa Biotech announces Phase 3 study of paridiprubart met primary endpoint

Edesa Biotech (EDSA) announced positive results from a Phase 3 study evaluating the company’s drug candidate paridiprubart as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The data from the Phase 3 study demonstrated that paridiprubart met primary and secondary endpoints with statistical significance. Paridiprubart led to a clinically significant reduction in mortality through 60 days, as well as a significant reduction in the proportion of patients requiring invasive mechanical ventilation. Edesa reported that paridiprubart in the most conservative intention-to-treat population met the primary endpoint, demonstrating a statistically significant and clinically meaningful benefit for reduced mortality at 28 days. Patients treated with paridiprubart plus standard of care treatments had a lower risk of death) compared to those receiving placebo, representing an absolute improvement in survival of 13% at 28 days with paridiprubart demonstrating a relative reduction in the risk of death of 25% compared to placebo.