Edesa Biotech Reveals Promising Phase 3 Results for ARDS Treatment

Edesa Biotech, Inc. announced significant findings from its Phase 3 clinical trial of paridiprubart (EB05), a promising treatment for Acute Respiratory Distress Syndrome (ARDS), which was showcased on October 28, 2025. The results indicate that paridiprubart not only met its primary and secondary endpoints but also demonstrated a substantial reduction in mortality rates among patients suffering from this severe respiratory condition.

The Phase 3 study highlighted that patients treated with paridiprubart, in combination with standard of care (SOC) therapies, exhibited a lower 28-day mortality rate of 39%, compared to 52% in the placebo group. This translates to an absolute improvement in survival of 13%, with a relative reduction in the risk of death by 25% (n=104; p<0.001). Additionally, at the 60-day mark, the mortality rate for patients receiving paridiprubart was 46%, compared to 59% for those on placebo, again reflecting a 13% improvement and a relative risk reduction of 22% (n=104; p=0.003). Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, expressed optimism regarding the findings, stating that they reinforce the transformative capabilities of EB05 in improving patient survival and outcomes in intensive care settings. He remarked, “These data indicate that paridiprubart provided a consistent and durable effect in patients across all severity groups evaluated.”

Details of the Study

Patients were recruited from 38 hospitals across Canada, the United States, and Colombia, and the study included individuals aged 18 and older who required invasive mechanical ventilation (IMV) at the time of hospitalization. Participants were randomly assigned to receive either paridiprubart (15 mg/kg, maximum dose of 1,400 mg, n=56) or a placebo (n=48). The primary efficacy endpoints measured were the 28-day and 60-day mortality rates, along with the proportion of patients achieving a ≥2-point improvement on the WHO COVID-19 Severity Scale (WCSS) at Day 28.

The safety data, which encompassed more than 275 subjects, indicated that EB05 was generally well-tolerated and aligned with previously observed safety profiles. The study was conducted under the oversight of JSS Medical Research, an established international contract research organization.

Potential Impact of Paridiprubart

Paridiprubart represents a new class of host-directed therapeutics (HDTs) that modulate the body’s immune response to various public health threats. This treatment is designed to be agnostic to the specific cause of the illness, allowing it to be stockpiled for rapid deployment during health emergencies. By inhibiting toll-like receptor 4 (TLR4), paridiprubart targets a critical immune signaling pathway implicated in the pathogenesis of various diseases, including ARDS.

Acute Respiratory Distress Syndrome is characterized by an exaggerated immune response that leads to significant lung inflammation and damage. It affects around 10% of intensive care unit admissions worldwide, accounting for over 3 million cases annually. Currently, available treatments are limited, making effective interventions like paridiprubart crucial for improving patient outcomes.

Edesa Biotech’s development program for paridiprubart has also received funding from the Government of Canada’s Strategic Innovation Fund, underscoring the potential significance of this treatment in the medical community. The company is also investigating additional applications for paridiprubart in chronic respiratory conditions, such as pulmonary fibrosis.

As the clinical landscape evolves, these Phase 3 results could pave the way for paridiprubart to become a standard treatment option for ARDS, offering hope to patients facing this critical condition.