Edesa Biotech Receives FDA Clearance to Expand Phase 2 Vitiligo Study to U.S.

Edesa Biotech, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the Phase 2 clinical study of its drug candidate, EB06, for vitiligo. This clearance allows the company to expand patient recruitment for the trial into the United States.

Key Details

• Drug & Indication: The Phase 2 study is evaluating EB06, a monoclonal antibody targeting CXCL10, in up to 80 adults with moderate-to-severe nonsegmental vitiligo.
• Regulatory Milestone: FDA clearance of the IND application enables the company to add U.S. investigational sites to its ongoing trial, which is currently recruiting patients in Canada.
• Projected Timeline: U.S. sites are expected to begin enrolling subjects in the next quarter, with topline data from the study anticipated in the fourth quarter of 2027.