Phase 1 Studies: AVX-001 and AVX-001-EXT

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PVX108 has been studied in AVX-001, a First in Human Phase 1 randomised double blind clinical trial to evaluate the safety and tolerability of PVX108 administered intradermally in adult participants with peanut allergy. The trial comprised 2 stages: a single ascending dose in 8 cohorts and a multiple dose stage in which participants received 6 doses over 16 weeks. During the study, participants were monitored for safety and tolerability and samples were collected for biomarker and immunological studies.

AVX-001-EXT was a follow-up study to AVX-001. Participants who completed Stage 2 in the AVX-001 study were followed up at Month 18. Blood samples taken for immunological and biomarker studies.

The studies demonstrated that PVX108 was safe and well tolerated in participants with peanut allergy, including participants with asthma. Biomarker and immunological studies demonstrated directional immunological changes which are relevant to the induction of tolerance to peanut protein.