Funpep Company Reports Positive Phase I Trial Results for Allergy Vaccine FPP004X

TOKYO, Jul 27 (Pulse News Wire) – FunPep Company Limited (4881.T) announced positive interim results from the Phase I clinical trial of its allergy vaccine candidate, antibody-inducing peptide FPP004X, targeting hay fever. The trial included two parts: Part 1 involved 45 healthy adults across three cohorts receiving varying doses of FPP004X, while Part 2 tested high-dose administration in 48 patients with seasonal allergic rhinitis.

Safety assessments showed no clinically significant adverse effects beyond typical local and systemic reactions associated with vaccines. Immunogenicity analysis revealed increased anti-IgE antibody levels in FPP004X recipients compared to placebo controls, with positivity rates of approximately 97% in Part 1 and 100% in Part 2. Peak antibody responses occurred four weeks post-final dose, followed by gradual decline through the final observation period. While exploratory evaluations did not show improvement in total six eye-nose symptom scores during cedar pollen exposure, the company remains optimistic.

FunPep signed an option agreement with Shionogi & Co. Ltd. in March 2024, granting Shionogi exclusive rights to pursue global development and commercialization based on future clinical outcomes. Discussions with Shionogi will continue to shape the development strategy for FPP004X.