Phase 1 Clinical Trials
Aravax is building a pipeline of immunotherapy candidates to tackle a range of food allergy indications
Phase 1 Clinical Trials
AVX-001 and AVX-001-EXT
AVX-001 was a First-in-Human Phase 1 randomised double blind, placebo controlled clinical trial to evaluate the safety and tolerability of PVX108 administered intradermally in adult participants with peanut allergy.
AVX-001
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 blood samples were collected for biomarker and immunological studies.
AVX-001-EX – Follow-Up Study to AVX-001
Participants who completed Stage 2 in the AVX-001 study were followed up at month 18. Blood samples were collected for biomarker and immunological studies.
Clinical Study Results
The studies demonstrated that PVX108 was safe and well tolerated in participants with peanut allergy, including participants with asthma and prior anaphylaxis to peanut. Biomarker and immunological studies demonstrated promising changes in the immune response to peanuts. Results from these studies have been published in the journal Allergy. Read more
PVX108 is an investigational drug product
PVX108 is undergoing clinical studies to evaluate the safety and effectiveness in humans. It has not received marketing authorization or approval by any regulatory agency, including the US Food and Drug Administration, or the Australian Therapeutic Goods Administration and the European Medicines Agency.
