Edesa Biotech Achieves Breakthrough in ARDS Treatment Study

Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, announced promising results from a Phase 3 study assessing the efficacy of its drug candidate, paridiprubart (EB05), for treating Acute Respiratory Distress Syndrome (ARDS). The results, released on October 28, 2025, indicate that paridiprubart significantly reduced mortality rates and the need for invasive mechanical ventilation among patients suffering from this life-threatening condition.

The Phase 3 study showed that paridiprubart achieved both primary and secondary endpoints with statistical significance. Specifically, patients treated with paridiprubart alongside standard of care (SOC) exhibited a 39% risk of death at 28 days, compared to 52% for those receiving a placebo. This translates to an absolute improvement in survival of 13% and a relative risk reduction of 25% (n=104; p<0.001).

Clinical Findings and Implications

The study also reported durable benefits at the 60-day mark, where the mortality rate for patients on paridiprubart plus SOC was 46%, versus 59% for the placebo group, again representing a 13% absolute improvement and a 22% relative reduction (n=104; p=0.003). Furthermore, subjects receiving paridiprubart showed a 41% higher relative rate of clinical improvement, with many no longer requiring invasive ventilation or organ support by Day 28.

Dr. Par Nijhawan, Chief Executive Officer of Edesa Biotech, remarked on the significance of these findings, stating that they highlight the potential of paridiprubart to transform patient outcomes in ARDS. “We are encouraged by these positive Phase 3 results, which demonstrated meaningful improvements in outcomes for patients,” he said. “These data indicate that paridiprubart provided a consistent and durable effect in patients across all severity groups evaluated.”

The study, which included over 275 subjects across 38 hospitals in the United States, Canada, and Colombia, revealed that paridiprubart was generally well-tolerated, aligning with previous safety profiles. The participants were aged 18 or older and were receiving invasive mechanical ventilation at the time of hospitalization.

Future Directions for Paridiprubart

Paridiprubart is currently part of the U.S. government’s “Just Breathe” initiative, which is investigating three novel therapeutics for hospitalized adults with ARDS. This development program has also secured funding from the Government of Canada’s Strategic Innovation Fund, underscoring the drug’s potential impact in treating respiratory illnesses.

Edesa Biotech is also exploring additional applications for paridiprubart in chronic conditions, including pulmonary fibrosis. As ARDS accounts for 10% of intensive care unit admissions globally, affecting over 3 million patients annually, the implications of this research extend far beyond individual treatment, potentially influencing global health strategies.

Edesa’s ongoing commitment to developing host-directed therapeutics (HDTs) highlights a shift towards treatments that modulate the body’s immune response to various health threats. By focusing on a drug that targets the immune system rather than specific pathogens, Edesa aims to create a versatile therapeutic option that can be stockpiled for public health emergencies.

The results from this study not only validate Edesa’s innovative approach but also place paridiprubart in a position to become a standard treatment option for ARDS and potentially other chronic respiratory conditions. As the company continues to navigate the clinical landscape, the future of paridiprubart appears promising, with the potential to significantly reduce mortality and improve quality of life for countless patients worldwide.