Edesa Biotech Reports 32% Mortality Reduction in AKI Patients with ARDS
EDSA•Edesa Biotech’s exploratory post hoc analysis of 101 AKI patients with ARDS showed paridiprubart plus SOC cut adjusted 28-day mortality to 33% from 49%, a 32% relative reduction, and reduced MAKE30 incidence by 23% to 41% versus 53%. Safety was consistent with prior trials, supporting further evaluation in AKI studies.
1. Exploratory AKI Data and Mortality Benefit
Edesa Biotech’s exploratory post hoc analysis of 101 hospitalized AKI patients with ARDS demonstrated that paridiprubart plus standard care lowered adjusted 28-day mortality to 33% from 49%, representing a 32% relative risk reduction (nominal p<0.005).
2. Kidney-Specific Outcomes and MAKE30
In kidney-specific evaluations, paridiprubart plus standard care cut the incidence of Major Adverse Kidney Events at Day 30 (MAKE30) to 41% from 53%, a 23% relative reduction (nominal p<0.005), based on multivariate logistic regression.
3. Patient Cohort Characteristics
The AKI subgroup incorporated 101 patients drawn from Phase 2 and Phase 3 ARDS studies; mean age was 58 years, around 90% had moderate-to-severe ARDS at baseline, and approximately half required invasive ventilation or ECMO, underscoring high mortality risk.
4. Safety Profile and Next Steps
Paridiprubart was well tolerated with no significant differences in adverse events, serious events or infections versus placebo, consistent with safety data from over 400 treated patients; these results support follow-up prospective trials focused on AKI populations.
