Forte Biosciences' FB102 Posts Statistically Significant Vitiligo Improvement in Phase 2 Trial
The clinical-stage biotech reported a 29.6% mean FVASI improvement from baseline at week 24, with the benefit widening progressively after treatment ended.
Forte Biosciences (FBRX), a clinical-stage biopharmaceutical company, reported that its lead asset FB102 achieved a statistically significant 29.6% mean improvement in the Facial Vitiligo Area Scoring Index from baseline at week 24 in the efficacy-evaluable population of its Phase 2 trial, yielding a placebo-adjusted benefit of 21.7 percentage points (p=0.020). The result marks the first disclosure of efficacy data from the study and positions FB102 as a potential treatment for a condition with limited approved therapies.
The data showed a progressive separation from placebo that widened well after the treatment period concluded. By day 64, the placebo-adjusted FVASI difference had reached statistical significance (p=0.023), and the gap continued to expand from 5.3 points at week 6 (p=0.059) to 21.7 points at week 24 (p=0.020). Between week 12, when treatment ended, and week 24, subjects gained an additional 8 percentage points of improvement, a trajectory the company said suggests a durable mechanistic effect.
In subjects with greater disease severity at baseline, the response was more pronounced. Those with a baseline FVASI of 0.75 or higher achieved a 43.2% mean improvement at week 24 (p=0.006), with 58.8% reaching a 50% improvement threshold and 23.5% reaching a 75% improvement threshold, compared with 0.5% for placebo. Among all FB102-treated subjects, 84% improved from baseline to week 24 and none worsened, while 27% of placebo subjects saw their condition deteriorate.
The safety profile remained clean, with no severe adverse events of Grade 3 or higher reported. Treatment-emergent adverse events occurred in 78.1% of FB102 subjects and 81.8% of placebo subjects, all classified as mild or moderate. Separately, FB102 received Fast Track Designation from the FDA for celiac disease during the quarter, a regulatory milestone that could accelerate the review pathway for that indication.
The company's spending reflected the expanding clinical footprint. Research and development expenses rose 61% year over year to $20.5 million in the first quarter of 2026, driven by $6.7 million in higher costs tied to the Phase 2 celiac and Phase 1b vitiligo and alopecia trials. General and administrative expenses fell 41% to $2.0 million, largely because a $2.3 million legal settlement in the year-earlier quarter did not recur.
The net loss widened to $22.1 million from $15.7 million a year earlier, though the loss per share narrowed to $1.24 from $1.37 as the weighted average share count rose to 17.8 million from 11.4 million. Cash and equivalents stood at $58.2 million at quarter-end, down $18.7 million sequentially from year-end 2025, but the position was bolstered by a $172.5 million gross equity raise in April 2026 that added 6.6 million shares.
The vitiligo Phase 1b topline results, previously flagged as expected in the first half of 2026, were reported as positive in the current release, completing a catalyst the company had telegraphed in prior quarters. With Fast Track status in hand for celiac and a growing cash runway, Forte now faces the task of translating Phase 2 vitiligo signals into a registrational path while its broader pipeline advances through early-stage studies.