Forte Biosciences has reported positive results from its double-blind, placebo-controlled Phase Ib trial assessing FB102 for vitiligo.
The study followed patients through 24 weeks, with a primary endpoint measuring mean per cent improvement from baseline in the facial vitiligo area scoring index (FVASI) after a 12-week treatment period.
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The trial enrolled 43 participants, with 32 randomised to FB102 and 11 to placebo. The intent-to-treat population saw FB102 achieve a 29.6% mean FVASI improvement from baseline at week 24, compared to a mean deterioration of 16.2% for a placebo.
This represented a placebo-adjusted benefit of 45.8% for FB102.
In the protocol-defined efficacy evaluable group, comprising 32 FB102 and ten placebo subjects, FB102 showed a 29.6% mean FVASI improvement at week 24, versus 7.9% for placebo, yielding a placebo-adjusted benefit of 21.7%.
Statistically significant response with FB102 was seen by day 64 and continued to improve through week 24 following the cessation of treatment at week 12.
A subgroup with baseline FVASI of at least 0.75, indicating more severe disease, experienced a mean 43.2% FVASI improvement at week 24 with FB102, compared to 0.5% for placebo.
In this group, 58.8% achieved FVASI50, and 23.5% reached FVASI75 at week 24, while placebo subjects did not reach these responder thresholds.
Across all study participants, 34.4% of those treated with FB102 reached FVASI50 and 12.5% achieved FVASI75 at week 24.
The majority of FB102 recipients maintained continued improvement during the follow-up period, with additional increases in FVASI scores noted between weeks 12 and 24.
Mild to moderate adverse events were reported, and FB102 was described as comparing favourably to placebo in terms of safety.
Forte Biosciences chairman and CEO Paul Wagner said: “With statistically significant placebo-controlled activity now demonstrated in vitiligo, and the prior Phase Ib activity demonstrated in celiac disease, we look forward to the imminent readout from our ongoing Phase II celiac disease trial as the next important clinical catalyst for FB102.
“Forte’s optimised FB102 blockade of CD122 was designed to modulate both IL-2– and IL-15–dependent pathogenic T-cell biology while preserving regulatory T cells, and clinical data to date support this profile.
“This may enable broader immune pathway modulation than IL-15 blockade alone and may avoid the regulatory T-cell modulation that can occur with overly potent CD122 inhibition. Data from this Phase Ib vitiligo study and from the previously reported Phase Ib trial in celiac disease reinforce the activity and broad potential for FB102.”
