EB06 Phase 2 Vitiligo Study Receives FDA IND Clearance

The FDA recently cleared the investigational new drug (IND) application for a phase 2 study of EB06 in moderate to severe nonsegmental vitiligo, according to Edesa Biotech. The clearance allows the company to expand recruitment to US investigational sites. Edesa expects topline data in the fourth quarter of 2027.¹

EB06 is a fully human monoclonal antibody targeting CXCL10, a signaling protein implicated in vitiligo. The IND clearance expands an ongoing study beyond Canada, and the company describes it as an important regulatory and operational milestone for the program.¹

Patient recruitment is underway in Canada, where Edesa’s clinical trial application was approved.² The first US investigational sites are expected to begin enrolling subjects next quarter.¹ Edesa selected JSS Medical Research as its clinical research organization in March 2026.²

The double-blind, placebo-controlled study will enroll up to 80 adults with moderate to severe nonsegmental vitiligo. Participants are randomized 1:1 to receive EB06 or placebo every 2 weeks through week 22. EB06 is currently formulated for intravenous administration.¹

The primary efficacy end point is the mean percent change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at week 28. No efficacy results have been reported for the study to date. Topline data are anticipated in the fourth quarter of 2027.¹

EB06 Secondary End Points, Safety, and Mechanism of Action

Secondary and exploratory measures include facial and total-body scoring benchmarks, as well as assessments of safety, tolerability, pharmacokinetics, and immunogenicity.¹

EB06 binds CXCL10 with high affinity and inhibits its interaction with the receptors CXCR3A and CXCR3B. According to Edesa, CXCL10 contributes to CXCR3A-mediated trafficking of anti-melanocytic CD8+ T cells to the epidermis and induces melanocyte apoptosis through CXCR3B. Edesa described this targeted mechanism as distinct from broader immunomodulatory approaches.¹

EB06 has been evaluated in 65 subjects across 3 prior clinical studies, according to the company.¹ In those studies, the antibody demonstrated pharmacodynamic activity relevant to its mechanism and was generally safe and well tolerated.¹ Edesa also reported preclinical work showing CXCL10 neutralization both prevented and reversed depigmentation.²

A subcutaneous formulation is anticipated to be ready for follow-on clinical evaluation. The company noted the safety and efficacy of EB06 remain subject to clinical evaluation.¹

Par Nijhawan, MD, chief executive officer of Edesa, said in the news release, “FDA clearance of our IND represents an important regulatory and operational milestone for our vitiligo program. 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.”¹

In March 2026, Nijhawan said, “Despite the high prevalence, there are few effective treatment options and no approved systemic therapeutics targeting the underlying disease.”² Edesa is positioning EB06 as a targeted biologic approach for this setting, with intravenous dosing in the current study and a subcutaneous formulation planned for later evaluation.¹˒²

References

1. Edesa Biotech announces FDA IND clearance for phase 2 vitiligo study. News release. Edesa Biotech. October 15, 2026. Accessed October 16, 2026. https://www.globenewswire.com//news-release/2026/10/15/3381747/0/en/edesa-biotech-announces-fda-ind-clearance-for-phase-2-vitiligo-study.html
2. Edesa Biotech advances vitiligo program for planned mid-2026 enrollment. News release. Edesa Biotech. March 26, 2026. Accessed October 16, 2026. https://www.globenewswire.com/news-release/2026/03/26/3263120/0/en/Edesa-Biotech-Advances-Vitiligo-Program-for-Planned-Mid-2026-Enrollment.html