EB06

October 15, 2026: Edesa Biotech, Inc. (NASDAQ: EDSA) said the FDA cleared the IND for its Phase 2 study of EB06 in vitiligo, allowing expansion of the ongoing trial to U.S. sites. Recruitment is already underway in Canada, with first U.S. sites expected to begin enrolling next quarter; topline data are anticipated in Q4 2027.

EB06 is a fully human anti-CXCL10 monoclonal antibody being studied in up to 80 adults with moderate-to-severe nonsegmental vitiligo. In the double-blind, placebo-controlled trial, patients are randomized 1:1 to EB06 or placebo every two weeks through Week 22. The primary endpoint is mean percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 28. Secondary and exploratory endpoints include facial and total-body scoring benchmarks plus safety, tolerability, pharmacokinetics, and immunogenicity.

The company also said EB06 has previously been evaluated in 65 subjects across three clinical studies, where it showed pharmacodynamic activity relevant to its mechanism and was generally safe and well tolerated. A subcutaneous formulation is anticipated for follow-on clinical evaluation.