FB102 Demonstrates Statistically Significant Efficacy
Forte Biosciences (NASDAQ:FBRX) shares rose 12% on Thursday after the clinical-stage biotechnology company announced encouraging data from its Phase 1b trial evaluating FB102 as a treatment for vitiligo.
The study showed that patients treated with FB102 achieved a mean improvement of 29.6% in Facial Vitiligo Area Scoring Index (FVASI) from baseline at week 24, compared with a 7.9% improvement in the placebo group. The result was statistically significant, with a p-value of 0.020.
The company said meaningful clinical improvement was observed by day 64 and continued through week 24, despite treatment ending after 12 weeks.
Greater Benefits Seen in Patients With More Extensive Disease
Among participants with more advanced vitiligo, defined as a baseline FVASI score of 0.75 or higher, FB102 delivered even stronger results.
Patients in this subgroup recorded a mean FVASI improvement of 43.2% by week 24, compared with just 0.5% for placebo, achieving a p-value of 0.006.
Additionally, 58.8% of these patients reached FVASI50, while 23.5% achieved FVASI75, indicating substantial improvements in facial repigmentation.
Improvement Continued After Treatment Ended
The randomized, double-blind, placebo-controlled trial enrolled 43 participants, with 32 receiving FB102 and 11 assigned to placebo.
The primary endpoint measured the average percentage improvement in FVASI from baseline using central review.
Forte Biosciences reported that most patients treated with FB102 continued to improve after completing the 12-week treatment period.
Across the overall treatment group, mean FVASI improvement increased by a further eight percentage points between weeks 12 and 24. Among patients with higher baseline disease severity, improvement expanded by an additional 14 percentage points over the same period.
Safety Profile Remains Favorable
The company also reported encouraging safety findings.
Overall, 84% of patients treated with FB102 showed improvement between baseline and week 24, while none experienced worsening disease during the study period.
By comparison, 27% of patients receiving placebo experienced disease progression over the 24-week trial.
All reported adverse events were classified as mild to moderate, with the safety profile of FB102 comparing favorably with placebo.