Edesa Biotech Receives the US FDA’s IND Clearance for P-II Study of EB06 to Treat Vitiligo
Shots:
- The US FDA has cleared Edesa Biotech’s IND application for its P-II study of EB06 in vitiligo, enabling expansion of recruitment to the US; recruitment is underway in Canada, with the first US sites expected to begin enrolling next quarter and topline data anticipated in Q4’27
- The double-blind, PBO-controlled study is evaluating EB06 vs PBO (1:1) Q2W through Wk. 22 in up to 80 adults with moderate-to-severe nonsegmental vitiligo; 1EP is mean % change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Wk. 28
- EB06 is a fully human mAb that binds CXCL10 and inhibits its interaction with CXCR3A & CXCR3B receptors, designed to interrupt immune-cell recruitment & melanocyte loss; it has been evaluated in 65 subjects across 3 prior clinical studies
Ref: Globenewswire | Image: Edesa Biotech | Press Release
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