INV4
4月前
Edesa Biotech Reports Additional Positive Results from Phase 3 Paridiprubart Study
Feb 24, 2026
Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today positive additional data from a Phase 3 study of paridiprubart.
The results represent a broader, 278-patient population, which includes both previously reported 104 patients requiring invasive mechanical ventilation (IMV) as well as 174 non-IMV patients. Across this full population, the company’s first-in-class anti-TLR4 antibody demonstrated a statistically significant reduction in 28-day mortality. Treatment benefits were consistent across severity groups and in patients with serious comorbidities.
Key Findings
The primary endpoint was achieved for the full treatment population of 278 randomized subjects. Paridiprubart reduced adjusted 28-day mortality to 24% from 33%, a 27% relative reduction in the risk of death (p<0.001). In addition, subjects receiving paridiprubart demonstrated a higher relative rate of clinical improvement by Day 28. Paridiprubart or placebo were provided in addition to standard of care treatments (SOC).
In an exploratory analysis of a milder population of 174 randomized patients who did not meet the study’s IMV-based inclusion criteria, paridiprubart + SOC reduced adjusted 28-day mortality to 15% from 23% (placebo + SOC), a 35% relative reduction in the risk of death (p<0.05).
Edesa also reported that exploratory analyses across a patient population of up to 108 randomized subjects consistently demonstrated reduced adjusted mortality for paridiprubart + SOC vs. placebo + SOC at 28 days in subjects with clinically important comorbidities:
• Acute Kidney Injury: 35% relative reduction (35% paridiprubart vs. 53% placebo; p<0.05, n=48)
• Sepsis: 36% relative reduction (40% paridiprubart vs. 63% placebo; p<0.05, n=41)
• Pneumonia: 30% relative reduction (35% paridiprubart vs. 49% placebo; p<0.05, n=108)
Overall rates of adverse events, serious adverse events, infections and treatment discontinuations were low and similar between the paridiprubart and placebo groups. The safety profile was consistent with prior clinical exposures, with more than 400 patients now having received paridiprubart.
Based in part on these positive results, Edesa has filed provisional patent applications with the United States Patent and Trademark Office covering the use of paridiprubart in the treatment of sepsis, acute kidney injury and pneumonia. The company’s core composition-of-matter patents extend into the 2030s.
Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, said that the results announced today align with the central role of TLR4 in hyperinflammatory ARDS (Acute Respiratory Distress Syndrome) and demonstrate consistent benefit across high-mortality etiologies.
“The consistency of mortality reduction and clinical improvement across all 278 randomized patients, including less severe patients as well as those with ARDS complicated by acute kidney injury, sepsis and pneumonia, underscores the versatility and transformative potential of paridiprubart to address multiple critical unmet medical needs,” said Dr. Nijhawan. “We are advancing regulatory discussions and evaluating strategic collaborations and partnership opportunities that could accelerate development and broaden global access.” He noted that manufacturing scale-up planning is underway.
Paridiprubart is currently being evaluated in a separate U.S. government-funded study of ARDS patients. Enrollment is ongoing for up to approximately 200 randomized subjects for the Edesa cohort. The company’s paridiprubart development program, including manufacturing scale-up, late-stage development and commercial readiness, also receives funding from the Government of Canada.
Edesa has been selected for an oral presentation at the American Thoracic Society (ATS) 2026 International Conference (May 15-20, 2026) and plans to present additional findings from its Phase 3 study at other upcoming medical and scientific conferences.
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Hopewillhelp
2年前
Nobody watches this stock and that's a mistake. 12 month minimum for full data analysis but we can get the interim data analysis much sooner. There was 125 patients enrolled in the Canadian P3 and that was 2 years ago. Recently, the Canadian P3 and the US P3 have been harmonized and the patient protocol has been changed to 600 total patients from the original 800. We could be closer than we think. Upon that data, the shares will double or triple, if I were Par, I would apply for EUA and the shares will rocket even further. He can then do an offering at a much higher valuation, and start the P2 Vitligo CXL-10, and EBO5 Fibrosis trials.