Aravax, a biotechnology company specializing in immunotherapies, has concluded patient recruitment for its Phase 2 clinical trial (AVX-201) evaluating PVX108, a novel immunotherapy for the treatment of peanut allergy. The study, conducted under an FDA Investigational New Drug Application, enrolled 95 children and adolescents aged 4 to 17 years across eight trial sites in the U.S. and six in Australia. This milestone marks a significant step forward in the development of a potentially safer and more convenient treatment option for individuals with peanut allergies.
PVX108: A Targeted Immunotherapy Approach
PVX108 is designed to 're-train' the immune system by administering engineered peptides that 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 absence of peanut proteins is intended to improve the safety profile and simplify administration.
The Phase 2 trial is a double-blind, placebo-controlled study assessing the safety and efficacy of two dose levels of PVX108 compared to placebo. Participants receive monthly administrations for one year. The primary endpoint 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. Data from Phase 1 trials indicated that PVX108 induced relevant changes in the immune response to peanut protein, with continued development observed post-dosing.
The Need for Improved Peanut Allergy Treatments
Peanut allergy affects millions worldwide, with prevalence rates continuing to rise, especially among children. Current management strategies primarily involve strict avoidance of peanuts and prompt treatment of allergic reactions with epinephrine. While oral immunotherapy (OIT) is available, it carries a risk of adverse reactions and requires a rigorous, long-term commitment. Therefore, there is a significant unmet need for safer, more convenient, and more effective therapies.
Aravax's Perspective
"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."
Trial Design and Anticipated Results
The AVX-201 trial is designed as a double-blind, placebo-controlled study. The primary endpoint focuses on the change in peanut tolerance as measured by a controlled food challenge. Secondary endpoints include assessing changes in immunological markers and evaluating the overall safety profile of PVX108. Headline results from the Phase 2 study are expected in the first half of 2026. If successful, this trial could pave the way for a Phase 3 study and eventual regulatory approval, offering a new treatment option for individuals with peanut allergy.
