EDSA News & Events

Edesa Biotech Inc trading halted, volatility trading pause

Edesa Biotech provided an update on preparations and reaffirmed enrollment timeline guidance for its Phase 2 clinical study of EB06 in moderate-to-severe nonsegmental vitiligo. The announcement coincides with the company's sponsorship and participation at the Global Vitiligo Foundation annual scientific symposium in Denver, Colorado. Edesa reported that it has selected JSS Medical Research, Inc. to act as its clinical research organization for the proof-of-concept study, and outreach to potential clinical sites and investigators has begun. Based on this progress, the company reaffirmed its previous guidance that site activations and patient recruitment are expected to begin mid-2026. Enrollment is anticipated to commence first at investigational sites in Canada, where Edesa's clinical trial application was approved. As planned, Edesa's Phase 2 study will evaluate the safety and efficacy of EB06 versus placebo in adults with non-segmental vitiligo. Patients will receive intravenous infusions of either EB06 or placebo during the treatment period, followed by a follow-up period.

Edesa Biotech announced 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 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. 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. 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. 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%, a 35% relative reduction in the risk of death. 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; Sepsis: 36% relative reductionl Pneumonia: 30% relative reduction. 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 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.