Forte Biosciences Inc. (NASDAQ:FBRX) on Thursday reported positive topline results from its Phase 1b trial evaluating FB102 in patients with vitiligo, a chronic autoimmune disorder where the immune system attacks melanocytes (pigment-producing cells).
The investigational therapy demonstrated statistically significant improvements in facial repigmentation, early treatment responses, and a favorable safety profile.
FB102 Met Primary Endpoint With Significant Improvement
The Phase 1b study enrolled 43 participants, randomizing 32 to FB102 and 11 to placebo.
The primary endpoint measured the mean percentage improvement from baseline in the Facial Vitiligo Area Scoring Index (FVASI).
In the protocol-defined efficacy-evaluable population, FB102 produced a mean FVASI improvement of 29.6% from baseline at week 24, compared with 7.9% for placebo, resulting in a placebo-adjusted benefit of 21.7%. The difference was statistically significant (p=0.020).
The company said treatment effects emerged early, with statistically significant improvement recorded by the day 64 assessment (p=0.023). Benefits continued through week 24 despite treatment ending after 12 weeks.
Patients With More Extensive Disease Saw Greater Benefit
Among patients with baseline FVASI scores of at least 0.75, representing roughly one-quarter of facial depigmentation, FB102 achieved a 43.2% mean improvement from baseline at week 24 versus 0.5% for placebo. The placebo-adjusted benefit reached 42.7%.
Within that subgroup, 58.8% of FB102-treated patients achieved FVASI50 while 23.5% reached FVASI75. By comparison, none of the placebo-treated patients achieved either endpoint.
Across the overall efficacy-evaluable population, 34.4% of FB102-treated patients achieved FVASI50, and 12.5% reached FVASI75.
Improvements Continued After Treatment Ended
Forte Biosciences said most FB102-treated patients continued improving after completing the 12-week treatment regimen.
Mean FVASI improvement increased by an additional 8 percentage points between weeks 12 and 24, while patients with higher baseline disease severity gained another 14 percentage points over the same period.
Overall, 84% of FB102-treated patients improved from baseline through week 24, and none experienced worsening disease. In contrast, 27% of placebo-treated patients worsened during the study period.
The company also said all adverse events were mild to moderate and that FB102 continued to compare favorably with placebo.
FBRX Price Action: Forte Biosciences shares were up 45.72% at $29.99 at the time of publication on Thursday, according to Benzinga Pro data.
Image via Shutterstock
