Edesa Biotech Announces FDA IND Clearance for Phase 2 Vitiligo Study
Key Highlights
- ➤FDA clears Edesa’s IND, enabling U.S. expansion of Phase 2 vitiligo study
- ➤U.S. investigational sites expected to begin enrolling subjects next quarter
- ➤Phase 2 study will evaluate EB06 in up to 80 adults with vitiligo
- ➤Topline data anticipated in fourth quarter 2027
Expert Statements
Par Nijhawan, Chief Executive Officer of Edesa Biotech
“FDA clearance of our IND represents an important regulatory and operational milestone for our vitiligo program”
Par Nijhawan, Chief Executive Officer of Edesa Biotech
“With recruitment already underway in Canada and U.S. enrollment expected to begin next quarter, we believe we are well positioned to complete the study and report topline results in the fourth quarter of next year.”
* Enables expansion of ongoing vitiligo clinical study to U.S. investigational sites * Topline data anticipated Q4 2027 TORONTO, Oct. 15, 2026 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for its Phase 2 clinical study of EB06 in vitiligo, enabling Edesa to expand recruitment to the United States. Patient recruitment is underway in Canada and the first U.S. investigational sites are expected to begin enrolling subjects next quarter. Edesa anticipates that topline data will be available fourth quarter 2027.
The double-blind, placebo-controlled clinical study is evaluating EB06, a monoclonal antibody targeting CXCL10, in up to 80 adults with moderate-to-severe nonsegmental vitiligo. Participants are randomized 1:1 to receive either EB06 or placebo every two weeks through Week 22. The primary efficacy endpoint is the mean percent change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at Week 28. Secondary and exploratory measures include facial and total-body scoring benchmarks, as well as assessments of safety, tolerability, pharmacokinetics and immunogenicity.
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