Edesa Biotech gets FDA clearance to add US sites to EB06 vitiligo trial

Edesa Biotech, Inc. disclosed in an 8-K filed October 15, 2026 that the FDA cleared the company's Investigational New Drug application for its Phase 2 clinical study of EB06 in vitiligo, allowing recruitment to expand into the United States.¹ Enrollment is already underway in Canada, and the company expects its first U.S. sites to begin enrolling patients in the following quarter.¹ Edesa said it expects topline data in the fourth quarter of 2027.¹

The study is a double-blind, placebo-controlled trial of EB06, described as a monoclonal antibody aimed at CXCL10, enrolling up to 80 adults with moderate-to-severe nonsegmental vitiligo.¹ Patients are assigned 1:1 to receive either EB06 or placebo, dosed every two weeks through Week 22.¹ The trial's primary efficacy measure is the average percent change from baseline in the Facial Vitiligo Area Scoring Index, assessed at Week 28.¹ Additional endpoints cover broader body and facial scoring measures along with safety, tolerability, pharmacokinetic and immunogenicity data.¹

On the drug itself, Edesa described EB06 as a fully human antibody directed at CXCL10, a protein the company links to vitiligo.¹ The company said that by blocking CXCL10, EB06 aims to stop immune cells from being drawn in and to prevent the loss of melanocytes, through a mechanism it describes as different from wider-acting immune therapies.¹ Edesa noted that EB06's safety and efficacy have not yet been established and remain under clinical study.¹