Edesa Biotech (NASDAQ: EDSA) has announced that the FDA has cleared the company’s Investigational New Drug (IND) application for its Phase 2 clinical study of EB06 in vitiligo, enabling Edesa to expand recruitment to the U.S.
According to Edesa, patient recruitment is underway in Canada and the first U.S. investigational sites are expected to begin enrolling subjects in the next quarter. The double-blind, placebo-controlled clinical study is evaluating EB06, a monoclonal antibody targeting CXCL10, in up to 80 adults with moderate-to-severe nonsegmental vitiligo. Edesa anticipates that topline data will be available fourth quarter 2027.
In a statement, Par Nijhawan, MD, CEO of Edesa, commented, “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.”
