Forte Biosciences Stock Surges on Positive Phase 1b Vitiligo Trial Data

Forte Biosciences (NASDAQ: FBRX) shares surged 12% on Thursday after the company announced positive results from its Phase 1b clinical trial of FB102, a therapeutic candidate for patients with vitiligo. The study met its primary endpoint, demonstrating a statistically significant improvement in repigmentation compared to a placebo.

Trial Meets Primary Endpoint

Forte reported that in the primary efficacy group, patients treated with FB102 achieved a 29.6% mean improvement from baseline on the Facial Vitiligo Area Scoring Index (FVASI) at week 24. This was significantly higher than the 7.9% improvement seen in the placebo group, yielding a p-value of 0.020.

The double-blind, placebo-controlled study enrolled 43 subjects. The company noted that a statistically significant treatment effect was observed as early as day 64 and that patient improvement continued through week 24, even after the 12-week treatment period had concluded.

Stronger Efficacy in High-Need Patients

The therapeutic effect was even more pronounced in a subset of patients with greater disease involvement at the start of the trial (baseline FVASI of 0.75 or higher). In this group, FB102 led to a 43.2% mean FVASI improvement, compared to just 0.5% for placebo, a highly significant result with a p-value of 0.006.

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Key achievements in this patient subgroup include:

• 58.8% of patients achieved at least a 50% improvement (FVASI50).
• 23.5% of patients achieved at least a 75% improvement (FVASI75).

Safety and Market Outlook

Forte Biosciences stated that FB102 was well-tolerated, with all adverse events reported as mild to moderate and a safety profile that compared favorably to placebo. Notably, 84% of subjects treated with FB102 showed improvement from baseline, while none worsened. In contrast, 27% of placebo subjects worsened over the 24-week period.

For investors, the positive Phase 1b data represents a critical early-stage validation for FB102. As a clinical-stage company, Forte will need to replicate these findings in larger, more advanced trials to move toward potential regulatory submission and commercialization.