Notice of Completion of Final Observation Day in Phase I Clinical Trial of Allergy Vaccine

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FunPep Co., Ltd. has completed the final observation day for the last patient in its Phase I clinical trial for FPP004X, an allergy vaccine under development for hay fever. Preliminary results are expected to be announced in the third quarter of 2026, indicating its potential as a new treatment option in the hay fever market.

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FunPep Co., Ltd. has completed the final observation day for the last patient in its Phase I clinical trial for FPP004X, an allergy vaccine under development for hay fever. Preliminary results are expected to be announced in the third quarter of 2026, indicating its potential as a new treatment option in the hay fever market.

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Source: https://prtimes.jp/main/html/rd/p/000000029.000142282.html | Date: Date unavailable

FunPep Co., Ltd. (Headquarters: Ibaraki City, Osaka; Representative Director and President: Toshimi Miyoshi) announced today the completion of the final observation day (LPO (Last Patient Out)) for the last patient in its Phase I clinical trial (hereinafter referred to as "this trial") for the allergy vaccine (antibody-inducing peptide FPP004X) currently under development for hay fever. Moving forward, we will proceed with the collection and analysis of all data from this trial, and preliminary results are scheduled to be disclosed in the third quarter of 2026 (July-September). This trial primarily evaluates the safety, tolerability, and immunogenicity (antibody production) of FPP004X when FPP004X or a placebo is repeatedly administered (intramuscularly) to healthy adults and patients with seasonal allergic rhinitis (hay fever). This trial consists of Part 1, targeting healthy adults, and Part 2, targeting patients with seasonal allergic rhinitis (hay fever). Part 1 was conducted in three stages: a low-dose cohort (two administrations at 4-week intervals) and a high-dose cohort (two administrations at 4-week intervals or three administrations at 4-week intervals). In Part 2 (three administrations at 4-week intervals), a pollen exposure chamber was used, in which pollen was artificially dispersed at a constant concentration, to confirm the reaction to Japanese cedar pollen. Hay fever is an allergic disease characterized by an excessive allergic reaction to pollen from plants such as Japanese cedar and cypress. Typical symptoms include sneezing, runny nose, nasal congestion, and itchy eyes. According to a nationwide epidemiological survey in Japan, the prevalence *i* in 2019 was 42.5% for hay fever overall and a high 38.8% for Japanese cedar pollinosis, which affects a large number of patients. Both figures have increased by more than 10% compared to 10 years prior (2008). The market for medicines (oral drugs) for allergic rhinitis, including hay fever, was approximat

Notice of Completion of Final Observation Day in Phase I Clinical Trial of Allergy Vaccine

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