Forte Biosciences FB102 shows vitiligo improvement in phase 1b trial

Forte Biosciences, Inc. (NASDAQ: FBRX) reported positive results from a double-blind, placebo-controlled phase 1b study of FB102 in vitiligo, according to a company statement.

The trial enrolled 43 subjects randomized 3:1, with 32 receiving FB102 and 11 receiving placebo. In the protocol-defined efficacy-evaluable population, FB102 achieved a 29.6% mean improvement from baseline in the Facial Vitiligo Area Scoring Index (FVASI) at week 24, compared to 7.9% for placebo, a placebo-adjusted benefit of 21.7% (p=0.020). Statistically significant improvement was observed as early as day 64 (p=0.023).

In subjects with greater disease involvement, defined as baseline FVASI of at least 0.75, FB102 achieved a 43.2% mean FVASI improvement at week 24 compared to 0.5% for placebo (p=0.006). In that subgroup, 58.8% of FB102-treated subjects achieved FVASI50 and 23.5% achieved FVASI75.

FB102-treated subjects continued to improve after completing the 12-week treatment period, with an additional 8 percentage point FVASI improvement between weeks 12 and 24. Among those with baseline FVASI of at least 0.75, the additional improvement was 14 percentage points over the same interval.

Overall, 84% of FB102-treated subjects improved from baseline through week 24, and none worsened. Among placebo subjects, 27% worsened during the same period.

All adverse events were mild to moderate, with FB102 comparing favorably to placebo.

Paul Wagner, PhD, Chairman and CEO of Forte Biosciences, said the company looks forward to "the imminent readout from our ongoing Phase 2 celiac disease trial as the next important clinical catalyst for FB102."

Forte Biosciences describes FB102 as a proprietary anti-CD122 monoclonal antibody candidate targeting autoimmune and autoimmune-related diseases.

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