Statistically Significant FB102 Benefit Observed By Day 64 and Continued through Week 24
FB102-Treated Subjects Continued Improving Through Week 24 After Completion of the 12-Week Treatment Period Supporting FB102 Mechanistic Modulation of Both IL-2– and IL-15–Dependent Pathogenic T-cell Biology while Preserving Regulatory T Cells
Forte will be Hosting a Conference Call to Discuss the Results at 8:30 am ET
DALLAS, July 09, 2026--(BUSINESS WIRE)--Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced positive results from the FB102 double-blind placebo-controlled phase 1b study in vitiligo:
FB102 achieved 29.6% mean FVASI improvement from baseline at week 24 (p-value = 0.020)
Response to FB102 was observed early, with statistically significant improvements observed by the day 64 visit (p=0.023), continuing through week 24, after completion of the 12-week treatment period.
FB102 achieved 43.2% mean FVASI improvement from baseline at week 24 (p-value = 0.006) in subjects with greater disease involvement having baseline FVASI ≥0.75 (approximately one-quarter of face depigmented), including:
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FVASI50 = 58.8%
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FVASI75 = 23.5%
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Responder endpoints in overall population achieved FVASI50 in 34.4% of FB102 treated subjects at week 24 with FVASI 75 achieved in 12.5% of FB102 treated subjects at week 24; this endpoint was impacted by one placebo FVASI75 responder, reinforcing the importance of randomized controlled studies and baseline severity when interpreting vitiligo responder endpoints.
The majority of FB102 treated subjects continued to improve through week 24 after completion of the 12-week treatment period with an additional 8 percentage point FVASI improvement between week 12 and 24.
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Among FB102-treated subjects with baseline FVASI ≥0.75 the mean FVASI improvement increased an additional 14 percentage points between week 12 and 24.
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84% (27/32) of FB102 treated subjects improved from baseline to week 24 following the 12-week treatment period and 0% (0/32) worsened. 27% (3/11) of placebo subjects worsened during the 24 week period.
FB102 continues to demonstrate a strong safety profile and compared favorably to placebo with only mild to moderate AEs.
These independent centrally-reviewed, placebo-controlled data demonstrate statistically significant FB102 mean FVASI improvements from baseline, with progressive improvement and a strong responder profile through week 24 after completion of the 12-week treatment period.