FunPep Company Limited's experimental hay-fever vaccine cleared its main safety and immune-response hurdles in a Phase 1 trial, but failed to ease allergy symptoms better than a placebo when tested against artificial cedar pollen exposure.
The trial ran two parts. Part 1 enrolled 45 healthy adults split across three dosing cohorts (12 on FPP004X and three on placebo in each). Part 2 enrolled 48 patients with seasonal allergic rhinitis in a fourth cohort, 24 on the drug and 24 on placebo, tested inside a pollen exposure chamber that released a controlled dose of Japanese cedar pollen over two consecutive days at screening and again 12 weeks after dosing.
On the two primary endpoints, FunPep reported good tolerability with no discontinuations from adverse events, and anti-IgE antibody titers rose in 35 of 36 Part 1 subjects, a 97 percent response rate, and in all 24 Part 2 subjects, 100 percent. Antibody levels peaked four weeks after the final injection and were still detectable at the trial's last observation point, roughly seven to eight months in.
The exploratory endpoint told a different story. In the pollen-chamber cohort, FunPep measured six combined eye and nose symptoms, including sneezing, nasal congestion, and eye itching, and found no improvement in the drug group compared with placebo.
FPP004X sits under a March 2024 option agreement with Shionogi & Co., which holds rights to acquire exclusive global development and commercialization rights across all diseases based on FunPep's trial data. FunPep said it will now discuss development policy for the drug with Shionogi. The company also confirmed the update carries no impact on its financial results for the year ending December 2026.