Edesa Biotech receives regulatory approval for Phase 2 vitiligo study

Edesa Biotech announced that it has received approval from Health Canada for a Phase 2 clinical study of the company’s EB06 monoclonal antibody candidate as a treatment for vitiligo. Edesa’s drug targets autoreactive T cells that destroy the pigment-producing cells of the epidermis. Specifically, EB06 binds to chemokine ligand 10 and inhibits the interaction of CXCL10 with its receptor. CXCL10 is highly expressed in vitiligo patients in both skin and serum, and CXCL10 is implicated in both the initiation of the disease and the maintenance of vitiligo lesions. Results from 65 subjects in three previous clinical studies demonstrated that EB06 produced the pharmacodynamic /biological activity required to address the dysfunctional immune response associated with vitiligo, and was generally safe and well tolerated. Preclinical studies have also demonstrated that neutralization of CXCL10 prevented and reversed depigmentation. As planned, the Phase 2 study protocol approved by Health Canada will evaluate the safety and efficacy of EB06 versus placebo in adults with moderate to severe non-segmental vitiligo. Patients will receive intravenous infusions of either EB06 or placebo during the treatment period, followed by a follow-up period. Approximately 120 adult subjects will be included in the double-blind, placebo-controlled study at up to approximately 25 investigational centers in Canada. The primary endpoint will be improvement from baseline on the Face Vitiligo Area Scoring Index, a quantitative clinical tool that estimates the overall area of vitiligo patches and the degree of macular re-pigmentation within these patches over time.