Edesa Biotech Achieves Breakthrough in ARDS Treatment Study

Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company based in Toronto, has reported promising results from its Phase 3 clinical trial for the drug candidate paridiprubart (EB05) aimed at treating Acute Respiratory Distress Syndrome (ARDS). This serious condition, characterized by severe respiratory failure, has limited treatment options and high mortality rates. The study’s findings indicate that paridiprubart significantly reduced mortality and the need for invasive mechanical ventilation among patients.

The Phase 3 trial demonstrated that paridiprubart met both primary and secondary endpoints with statistical significance. Specifically, patients receiving paridiprubart in conjunction with standard care treatments exhibited a 39% risk of death at 28 days, compared to 52% for those receiving a placebo. This data translates to an absolute improvement in survival of 13%, indicating a 25% relative reduction in the risk of death (n=104; p<0.001). A similar trend continued at 60 days, where the mortality risk for patients treated with paridiprubart plus standard care was 46%, versus 59% for the placebo group, yielding another 13% absolute improvement and a 22% relative risk reduction (n=104; p=0.003).

Trial Details and Patient Outcomes

The study included participants from 38 hospitals across the United States, Canada, and Colombia. Eligible patients were 18 years or older and required invasive mechanical ventilation, with or without additional organ support. They were randomly assigned in a 1:1 ratio to receive either paridiprubart (15 mg/kg, maximum dose 1,400 mg, n=56) or a placebo (n=48). The primary efficacy outcomes measured were mortality rates at 28 days and 60 days, along with clinical improvement as assessed by the WHO COVID-19 Severity Scale.

The results also revealed that patients treated with paridiprubart demonstrated a 41% higher relative rate of clinical improvement, meaning they no longer required invasive mechanical ventilation or organ support by Day 28. The safety profile of paridiprubart has been consistent with past observations, as reported in a safety population of over 275 subjects.

Dr. Par Nijhawan, Chief Executive Officer of Edesa Biotech, emphasized the significance of these findings, stating that the Phase 3 data highlight the potential of paridiprubart to transform outcomes for patients suffering from this critical condition. “We believe that these findings not only validate our therapeutic approach but also support paridiprubart’s potential use as a standard treatment for ARDS, and possibly for chronic respiratory conditions as well,” he remarked.

Funding and Future Prospects

Edesa Biotech’s development program for paridiprubart benefits from financial support from the Government of Canada’s Strategic Innovation Fund. The drug is also being evaluated in the U.S. government’s “Just Breathe” study, which investigates novel therapeutics for hospitalized adult patients with ARDS.

Paridiprubart represents a new class of host-directed therapeutics (HDTs) designed to modulate the immune response to various public health threats, including infectious diseases and other emergencies. By inhibiting toll-like receptor 4 (TLR4), paridiprubart addresses immune signaling activated by a range of pathogens and injuries.

As ARDS accounts for approximately 10% of intensive care unit admissions globally, affecting over 3 million patients each year, the implications of these findings are substantial. With limited treatment options currently available, the potential for paridiprubart to improve patient outcomes could significantly impact the management of this life-threatening syndrome.

Edesa Biotech continues to advance its clinical pipeline, with a focus on innovative therapies for inflammatory and immune-related diseases, as it seeks to broaden the applications of paridiprubart for chronic conditions, including pulmonary fibrosis. The company is committed to ongoing research and development efforts aimed at addressing critical health challenges.