Jasper Therapeutics announced positive preliminary results from the BEACON Phase 1b/2a trial, evaluating briquilimab for the treatment of chronic spontaneous urticaria (CSU). The data indicate rapid, deep, and sustained clinical responses with a favorable safety profile, suggesting a potential new treatment option for patients with this debilitating condition.
BEACON Study Highlights
The BEACON study assessed subcutaneous briquilimab in adult participants with CSU. Key findings include:
- A mean change in UAS7 (Urticaria Activity Score over 7 days) from baseline of -26.6 was observed in the 240mg single-dose cohort at 8 weeks.
- Multiple dosing regimens at or above 120mg demonstrated UAS7 changes of more than -25 points.
- Notably, 100% (N=3) of patients in the 240mg single-dose cohort achieved Complete Responses (UAS7 = 0) at 8 weeks, with 66% maintaining well-controlled disease at 12 weeks.
- Reductions in serum tryptase levels below the lower limit of quantification were observed at multiple dose levels.
Clinical Implications
These results suggest that briquilimab could offer a significant improvement in the management of CSU. The rapid onset of action, combined with the durability of response and favorable safety profile, positions briquilimab as a potentially valuable therapy, especially for patients who have previously been treated with omalizumab. According to Dr. Thomas B. Casale, Professor of Medicine and Pediatrics at the University of South Florida Morsani College of Medicine, the data supports advancing briquilimab into a registrational program.
Briquilimab Mechanism of Action
Briquilimab is a novel antibody therapy targeting c-Kit (CD117), a receptor tyrosine kinase expressed on mast cells. By blocking c-Kit, briquilimab aims to address mast cell-driven diseases such as CSU, chronic inducible urticaria (CIndU), and asthma. Reductions in serum tryptase, an indicator of mast cell activation, further support the drug's mechanism of action.
Next Steps
Jasper Therapeutics anticipates commencing a registrational program for CSU in the second half of 2025. Further studies are planned to evaluate briquilimab in chronic urticaria.
