Aravax has received Fast Track designation from the US FDA for PVX108, an investigational immunotherapy for the treatment of peanut allergy.
PVX108 is a peptide-based immunotherapy designed to retrain the immune system to tolerate peanut proteins while minimising the risk of treatment-induced acute allergic reactions. The therapy is currently being evaluated in an international phase 2 clinical trial involving sites in the US and Australia, with topline data expected later this year.
PVX108 is a next-generation immunotherapy which uses proprietary peptides designed to precisely retrain the immune system to tolerate peanut whilst avoiding treatment-induced acute allergic reactions. Phase 2 studies of PVX108 are ongoing at clinics in the United States and Australia with key data anticipated to be reported later in 2026.
People with peanut allergy face a lifelong risk of severe allergic reactions, including anaphylaxis, and treatment options remain limited. Current management largely relies on strict allergen avoidance and emergency treatment of accidental exposures.
Pascal Hickey, CEO of Aravax, said: “There remains a critical need for effective new treatments for food allergy and we believe PVX108 has the potential to offer a safer, more convenient and disease modifying treatment for the millions affected by peanut allergy worldwide.
“Receiving FDA Fast Track designation is a significant step for PVX108’s future development as being able to communicate more frequently with the FDA often leads to early drug approval and access by patients.”
The FDA’s Fast Track programme can provide eligible therapies with more frequent regulatory meetings and written communications, as well as potential eligibility for rolling review, priority review and accelerated approval where the relevant criteria are met.
Aravax is a clinical stage biotechnology company focused on revolutionising the treatment of food allergies with next-generation, disease-modifying immunotherapies which are safer and more convenient than existing approaches. The company is also developing a broader pipeline of peptide-based immunotherapies targeting additional food allergies.