FDA Clears Edesa IND for Phase 2 EB06 Vitiligo Study

Quiverquant reports that Edesa Biotech received U.S. Food and Drug Administration clearance for an Investigational New Drug application supporting a Phase 2 study of EB06 in vitiligo.

According to Quiverquant, the clearance allows Edesa to expand patient recruitment for the study to sites in the United States. The program is intended to evaluate EB06 in adults with moderate vitiligo.

IND clearance enables U.S. site enrollment

The FDA clearance is the regulatory event reported by Quiverquant for Edesa’s Phase 2 EB06 program. Edesa can expand enrollment to U.S. sites under the cleared IND, according to the publisher.

Quiverquant states that the study is planned to include up to 80 adults with moderate vitiligo. The reported trial objective is to evaluate the efficacy of EB06 in this population.

EB06 is described as a CXCL10-targeting antibody

Quiverquant describes EB06 as a monoclonal antibody targeting CXCL10. The FDA IND clearance and expansion of recruitment to U.S. sites are the reported next steps for the Phase 2 study.

For pharmaceutical and biotech professionals following dermatology development programs, the update identifies a regulatory clearance tied to the study’s enrollment expansion. Quiverquant reports that Edesa anticipates topline data from the program.

Reported study details

• The FDA cleared Edesa Biotech’s IND application for a Phase 2 EB06 study in vitiligo.
• The clearance enables patient recruitment to expand to U.S. sites.
• The study is planned to enroll up to 80 adults with moderate vitiligo.
• EB06 is described as a monoclonal antibody targeting CXCL10.
• Quiverquant reports that Edesa anticipates topline data.