Canadian clinical-stage biopharmaceutical company Edesa Biotech, Inc. (NASDAQ: EDSA) said on Thursday it has received US FDA clearance for its Investigational New Drug application for EB06 in vitiligo.

The approval allows the company to add US sites to its ongoing Phase 2 trial, with American recruitment expected to begin next quarter and top-line data anticipated in the fourth quarter of 2027.

The double-blind, placebo-controlled study is assessing EB06, a monoclonal antibody targeting CXCL10, in up to 80 adults with moderate-to-severe nonsegmental vitiligo. Subjects are randomised to EB06 or placebo every two weeks through Week 22, with the primary endpoint measuring mean percentage change from baseline in the Facial Vitiligo Area Scoring Index at Week 28.

Secondary and exploratory measures include facial and total-body scoring benchmarks, alongside safety, tolerability, pharmacokinetics and immunogenicity assessments. EB06 is designed to inhibit CXCL10, a signalling protein implicated in immune-cell recruitment and melanocyte loss, and its safety and efficacy remain under clinical evaluation.

The antibody has previously been studied in 65 subjects across three trials, demonstrating pharmacodynamic activity consistent with its mechanism and showing a generally favourable safety profile. It is currently formulated for intravenous administration, with a subcutaneous version planned for future studies.