Forte Biosciences' FB102 Hits Key Goal in Vitiligo Study, Shows Durable Improvement

Forte Biosciences said FB102 met its primary endpoint in a small placebo-controlled vitiligo study, showing a statistically significant improvement in facial Vitiligo Area Scoring Index at week 24 versus placebo. The company highlighted durable benefits after treatment ended : patients continued improving off therapy, with response becoming significant by day 64 and remaining so through week 24. Safety looked favorable , with mostly mild-to-moderate adverse events, while experts on the call called the results a strong signal for the program but noted the study was small and needs larger trials for confirmation. Forte Biosciences NASDAQ: FBRX said FB102 showed statistically significant improvement in a small placebo-controlled vitiligo study, with Chief Executive Officer Paul Wagner highlighting continued improvement after patients stopped treatment as a key feature of the results. On a company data call, Wagner said the trial evaluated FB102, an antibody designed to block CD122 and modulate IL-2 and IL-15 signaling involved in pathogenic T-cell activity. Forte is studying the drug in autoimmune diseases, including vitiligo and celiac disease. Vitiligo is an autoimmune skin disease in which pathogenic T cells attack melanocytes, causing depigmentation. Wagner said the disease remains an area of significant unmet need despite the approval of a topical JAK inhibitor and development of oral JAK inhibitors, noting regulatory scrutiny and black box warnings for the JAK class. The vitiligo study enrolled 43 subjects randomized three-to-one, with 32 patients receiving FB102 and 11 receiving placebo in the intent-to-treat population. The company said patien...