Aravax will present topline Phase 2 clinical trial results for PVX108, an investigational immunotherapy for peanut allergy, at scientific meetings in the US and Europe in November.

The Melbourne, Australia-based biotechnology company said the data will be presented at the Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Phoenix from 12–16 November, followed by the European Academy of Allergy and Clinical Immunology (EAACI) Food Allergy Anaphylaxis and the European Consortium on Application of Flow Cytometry in Allergy (FAAM-EUROBAT-ISMA) Congress in Utrecht from 19–21 November.

The results will provide a closer look at the efficacy and safety of PVX108 in children with peanut allergy.

Phase 2 trial evaluated monthly PVX108 treatment

The Phase 2 study, registered as NCT05621317, was conducted at trial sites in the US and Australia.

The randomised, double-blind, placebo-controlled trial enrolled participants with peanut allergy into two cohorts: a pilot safety cohort involving adolescents and a primary efficacy cohort involving children aged four to 11 years.

Participants received intradermal PVX108 or placebo in monthly doses over 12 months. The study was designed to evaluate the treatment’s efficacy and safety.

Aravax said the topline results will be communicated at the two November meetings, although the company has not yet released the findings.

Peptide immunotherapy targets peanut allergy

PVX108 is an investigational immunotherapy based on peptides designed to target the immune response to peanut allergens.

The approach is intended to retrain the immune system to tolerate peanut while avoiding acute allergic reactions associated with some whole-allergen immunotherapy approaches.

Aravax CEO Dr Pascal Hickey said: “We are excited to be able to share new Phase 2 top-line data with a wide audience at these two important scientific meetings in November. We believe that PVX108 has the potential to provide a highly differentiated treatment option by minimizing the risks of acute allergic reactions during treatment which complicate whole-allergen approaches, whilst promoting immune tolerance.”

The company said PVX108 has received FDA Fast Track designation for the treatment of peanut allergy.

The forthcoming Phase 2 data will be important in assessing whether the peptide-based approach can demonstrate a clinically meaningful benefit in children with peanut allergy, as well as providing further information on its safety profile.

The trial results are expected to provide more detail on the potential of PVX108 as a disease-modifying treatment for peanut allergy and whether the findings support further clinical development.