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AVX-001 and AVX-001-EXT

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.

AVX-201

AVX-201 is a double blind randomised Phase 2 study in adolescents and children with peanut allergy. The aims of the trial are to evaluate the efficacy and safety of PVX108 when administered intradermally in monthly doses over a 12 month period. The US FDA has approved an IND and the trial will be conducted at sites in Australia and in the US. Detailed planning is underway and the trial is expected to commence later in 2022.

Are you interested in participating in future trials?

Please contact info@aravax.com.au