Aravax, a biotechnology company focused on developing targeted immunotherapies, has announced the completion of patient recruitment for its Phase 2 study (AVX-201) of PVX108, a novel immunotherapy for the treatment of peanut allergy. The study, conducted under a U.S. FDA Investigational New Drug Application, enrolled 95 children and adolescents aged four to 17 years across eight trial sites in the U.S. and six in Australia.
PVX108: A Precision Immunotherapy
PVX108 is designed to 're-train' the immune system by administering engineered peptides to precisely target T cells, aiming to reverse the course of allergic disease. Unlike many existing or developing treatments for peanut allergy, PVX108 does not contain peanut proteins, which can pose a risk of serious side effects and necessitate complex dosing regimens. The therapy is administered monthly for one year via intradermal injection, utilizing a needle-free system.
Study Design and Endpoints
The Phase 2 study is a double-blind, placebo-controlled trial evaluating the safety and efficacy of two dose levels of PVX108 compared to placebo. In Phase 1 trials, PVX108 demonstrated changes in the immune response to peanut protein, which continued to develop after dosing was completed. The primary endpoint of the Phase 2 study is the ratio of maximum tolerated dose of peanut protein in a controlled food challenge at the end of the study period relative to baseline. Headline results are expected in the first half of 2026.
Management Commentary
"The timely completion of recruitment across multiple sites in the U.S. and Australia is a significant step for Aravax," said Dr. Pascal Hickey, CEO of Aravax. "There remains a critical need for better treatments for serious food allergies. PVX108 has been designed to provide a safe and convenient treatment which has the potential to reverse the course of allergic disease. We look forward to continuing evaluation of PVX108 efficacy in this potentially Phase 3-enabling study."
About PVX108's Mechanism
PVX108 contains a mixture of synthetic peptides designed to precisely target the T cells that drive peanut allergy. Each peptide represents a dominant T cell epitope from major peanut allergens and has been engineered to be incapable of triggering acute allergic reactions. This approach aims to provide a safe, convenient, and long-lasting treatment with monthly dosing through essentially needle-free intradermal administration.
