Forte Biosciences (FBRX) Update / Briefing Transcript

Summary of Forte Biosciences (FBRX) Investor Webcast - June 23, 2025 Company Overview - Company: Forte Biosciences (FBRX) - Focus: Development of FV102, an antibody targeting celiac disease and other autoimmune conditions Key Points from the Call Industry and Product Development - Celiac Disease: Affects approximately 2.5 million people in the U.S., often underdiagnosed due to lack of treatment options [10] - FV102: An antibody targeting CD122, involved in the immune response related to celiac disease, showing positive results in Phase 1b trials [5][6] - Phase 2 Study: Initiating a Phase 2 trial with 100 patients, focusing on efficacy and safety, with data expected in 2026 [29][30] Clinical Trial Results - Phase 1b Trial: - 32 subjects enrolled, randomized 3:1 (FV102 to placebo) [17] - Positive histological and symptom data observed in treated subjects compared to placebo [5] - Significant reduction in intraepithelial lymphocyte (IEL) density in the FV102 group, indicating reduced inflammation [23] - 42% reduction in gluten-induced symptoms in the FV102 group, including nausea and abdominal pain [25][26] Mechanism of Action - Mechanism: FV102 blocks IL-2 and IL-15 signaling, preventing activation of autoreactive T cells and NK cells, while sparing regulatory T cells [6][7] - Targeted Diseases: Besides celiac disease, FV102 shows potential in treating vitiligo, alopecia, and type 1 diabetes [6][31] Safety Profile - Adverse Events: Only one grade 3 adverse event reported in the placebo group; overall safety profile consistent with previous studies [27][28] Future Directions - Phase 2 Trial Design: Will include a higher gluten challenge and focus on both histological and symptom endpoints [40][41] - Long-term Goals: Aim to demonstrate protection from gluten-induced gut damage and symptomatology, which could set the stage for future trials [64] Competitive Landscape - Comparison with Other Treatments: FV102's dual blockade of IL-2 and IL-15 is seen as a significant advantage over other therapies that focus solely on IL-15 [58][60] Additional Insights - Clinical Relevance: A change of around 30% in IEL count is considered significant for clinical benefit [37] - Patient Experience: Participants reported high tolerability to FV102, with many experiencing no symptoms during gluten challenges [60] Conclusion - Forte Biosciences is advancing its clinical development of FV102 for celiac disease, with promising Phase 1b results leading to a Phase 2 trial. The company aims to address significant unmet needs in autoimmune diseases through innovative therapeutic mechanisms.