Edesa Biotech has announced positive results from a Phase III clinical trial of its drug candidate, paridiprubart (EB05), for acute respiratory distress syndrome (ARDS).
The study results showed that paridiprubart achieved statistically significant improvements in both primary and secondary endpoints, including decreased mortality through 60 days and a reduced need for invasive mechanical ventilation (IMV).
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The drug met the primary endpoint in the intention-to-treat population demonstrating a reduction in mortality at 28 days.
Participants who received paridiprubart combined with standard of care (SOC) showed a 39% lower risk of death, compared to 52% with placebo, highlighting a 13% improvement in survival and a relative decline in risk of death by 25%.
Survival benefit was demonstrated at 60 days. Paridiprubart plus SOC reduced the risk of death to 46% compared to 59% with placebo, representing another 13% absolute improvement in survival and a relative risk reduction of 22% for the drug against placebo.
Additionally, participants receiving paridiprubart and SOC showed a 41% higher relative clinical improvement rate, with subjects no longer requiring organ support or IMV by day 28.
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By GlobalDataA safety analysis across more than 275 participants confirmed EB05 was generally consistent and well-tolerated, in line with earlier observations.
Edesa Biotech CEO Par Nijhawan said: “We are encouraged by these positive Phase III results, which demonstrated meaningful improvements in outcomes for patients. These data indicate that paridiprubart provided a consistent and durable effect in patients across all severity groups evaluated.
“We believe that these findings not only provide important validation of our therapeutic approach but also support paridiprubart’s potential use as a standard of care treatment for ARDS, and potentially chronic respiratory indications as well.”
Paridiprubart is also being studied in the US Government’s Just Breathe trial for ARDS.
