Melbourne, Australia – 28 October 2024, Aravax, a clinical-stage biotechnology company developing next-generation immunotherapies designed to be safe, convenient, and precisely targeted, today announces it has completed patient recruitment into its Phase 2 study (AVX-201) of its novel, precision therapy PVX108 for the treatment of peanut allergy.
Aravax’s PVX108 is an advanced immunotherapy designed to ‘re-train’ the immune system by administering engineered peptides to precisely target T cells and reverse the course of allergic disease. Unlike most treatments available, or under development for peanut allergy, PVX108 does not contain peanut proteins which put patients at significant risk of serious side effects, which leads to complex and burdensome dosing regimens.
The study, which is being conducted under an U.S. FDA Investigational New Drug Application, has enrolled 95 patients across eight trial sites in the U.S. and six in Australia. Trial participants were children and adolescents aged four to 17 years with peanut allergy. The trial is a double-blind, placebo-controlled study designed to evaluate the safety and efficacy of two dose levels of PVX108 versus placebo, administered monthly for one year.
In Phase 1 trials, researchers observed that PVX108 produced relevant changes in the immune response to peanut protein, which continued to develop once dosing had completed. The primary endpoint of this Phase 2 study is 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 H1 2026.
Dr Pascal Hickey, CEO of Aravax, said: “The timely completion of recruitment across multiple sites in the U.S. and Australia, is a significant step for 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.”
ENDS
About Aravax Aravax is a clinical stage biotechnology company focused on revolutionising the treatment of food allergies with next-generation specific immunotherapies which are safe, effective and convenient. Aravax applies proprietary technology and know-how to design highly targeted immunotherapies, which reset the immune system to tolerate a specific allergen without evoking allergic reactions during treatment. The lead product, PVX108, is being developed for the treatment of peanut allergy. Founded in 2015 based on technology from Alfred Health and Monash University, Aravax is a private company headquartered in Melbourne. Its investors include Brandon Capital, Tenmile, Novartis Venture Fund, Breakthrough Victoria, Uniseed, UniSuper and Agati Capital.
For more information visit: www.aravax.com.au
About PVX108 PVX108 is an innovative precision immunotherapy containing a mixture of synthetic peptides which are designed to precisely target the T cells which drive peanut allergy. Each peptide represents a dominant T cell epitope from major peanut allergens. PVX108 does not contain natural extracts or whole allergens and has been engineered to be incapable of triggering acute allergic reactions. It has been designed to provide a safe, convenient and long-lasting treatment with monthly dosing through essentially needlefree intradermal administration.
For further information please contact Media – Australia Kirrily Davis, E: kdavis@bcpvc.com M: +61 (0)401 220228
Media – International Sue Charles, Charles Consultants E: sue.charles@charles-consultants.com M: +44 (0)7968 726585
