Edesa Biotech Advances Vitiligo Program for Planned Mid-2026 Enrollment

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TORONTO, March 26, 2026 (GLOBE NEWSWIRE) — Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today provided an update on preparations and reaffirmed enrollment timeline guidance for its Phase 2 clinical study of EB06 in moderate-to-severe nonsegmental vitiligo. The announcement coincides with the company’s sponsorship and participation today at the Global Vitiligo Foundation (GVF) Annual Scientific Symposium in Denver, Colorado.

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Edesa reported that it has selected JSS Medical Research, Inc. to act as its clinical research organization (CRO) for the proof-of-concept study, and outreach to potential clinical sites and investigators has begun. Based on this progress, the company reaffirmed its previous guidance that site activations and patient recruitment are expected to begin mid‑2026. Enrollment is anticipated to commence first at investigational sites in Canada, where Edesa’s clinical trial application was approved (subject to administrative filings that may be required for protocol updates).

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Par Nijhawan, MD, Chief Executive Officer of Edesa said that ongoing engagement with leaders in the vitiligo community has been an important part of refining the company’s clinical strategy. “Discussions with key opinion leaders, including those taking place at the vitiligo conference this week, have informed our Phase 2 trial design and plans, as we seek to align our development with the needs of both patients and treating physicians.”

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“Developing an effective and well-targeted biologic drug – especially for high body surface areas – would have a significant impact on treating vitiligo. Despite the high prevalence, there are few effective treatment options and no approved systemic therapeutics targeting the underlying disease,” Dr. Nijhawan said

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Vitiligo is a chronic autoimmune disease that causes the loss of skin pigmentation in patches. It occurs when pigment-producing skin cells, melanocytes, are targeted and destroyed by autoreactive T-cells. CXCL10, the target of Edesa’s drug, has been shown to play both a key role in the trafficking of these anti-melanocytic T-cells to the epidermis as well as in inducing cell death. Elevated levels of CXCL10 are associated with the initiation of the disease as well as the maintenance of vitiligo lesions.

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As planned, Edesa’s Phase 2 study will evaluate the safety and efficacy of EB06 versus placebo in adults with non-segmental (generalized) vitiligo. Patients will receive intravenous infusions of either EB06 or placebo during the treatment period, followed by a follow-up period.

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About EB06

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EB06 is a monoclonal antibody candidate that binds specifically and selectively to chemokine ligand 10 (CXCL10) and inhibits the interaction of CXCL10 with its receptor(s). CXCL10 is highly expressed in vitiligo patients, and has been shown to play both a key role in the trafficking of anti-melanocytic T-cells to the epidermis as well as directly induces melanocyte apoptosis (cell death) via CXCR3B activation. Furthermore, EB06 neutralization of CXCL10 has been demonstrated to both prevent and reverse depigmentation in preclinical studies. 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. EB06 is currently formulated for intravenous administration, with a subcutaneous formulation anticipated to be ready for follow-on clinical evaluation.