FB102
- Indication
- Vitiligo
- Stage
- phase1
- Event
- Phase 1b
- Details
July 9, 2026: Forte Biosciences, Inc. (NASDAQ: FBRX) reported positive results from its double-blind, placebo-controlled Phase 1b trial of FB102 (anti-CD122 mAb) in vitiligo, with the primary endpoint of mean percent Facial Vitiligo Area Scoring Index (FVASI) improvement from baseline assessed by central review.
In the protocol-defined efficacy-evaluable population (FB102 n=32; placebo n=10), FB102 produced a 29.6% mean FVASI improvement at week 24 vs 7.9% for placebo (placebo-adjusted benefit 21.7%; p=0.020). Statistically significant improvement was observed by day 64 (p=0.023) and continued through week 24, including after completion of the 12-week treatment period. In subjects with baseline FVASI ≥0.75, mean FVASI improvement was 43.2% at week 24 vs 0.5% for placebo (placebo-adjusted benefit 42.7%; p=0.006), with FVASI50 58.8% and FVASI75 23.5%.
Safety: AEs were mild/moderate and compared favorably to placebo.
Upcoming catalyst: the company cited an “imminent readout” from its ongoing Phase 2 celiac disease trial of FB102. A conference call to discuss results was scheduled for 8:30 a.m. ET.
- Source
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