- Primary endpoint achieved: PVX108 therapy increased the maximum tolerated dose of peanut compared to placebo following a convenient, once-monthly treatment course over 12 months, while demonstrating a highly favourable safety and tolerability profile
- Multiple secondary and exploratory objectives were also met, including a significant reduction in emotional impact of allergy reported by children following PVX108 therapy compared to placebo
- Evidence of maintenance of effect of PVX108 therapy following six months off-treatment, indicating potential for disease-modification
- Results to be unveiled in late-breaking oral presentation at The Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology (ACAAI)
MELBOURNE, Australia and OXFORD, United Kingdom, Nov. 12, 2026 (GLOBE NEWSWIRE) -- Aravax, a clinical-stage biotechnology company developing next-generation therapies for food allergy, today announces positive topline results in children from its Phase 2 clinical trial involving its lead product, PVX108 for the treatment of peanut allergy.
PVX108 is an investigational, next-generation immunotherapy which uses proprietary peptides designed to precisely retrain the immune system to tolerate peanut whilst minimising treatment-induced acute allergic reactions. It has been awarded FDA Fast Track designation for the treatment of peanut allergy.
Dr Pascal Hickey, CEO, Aravax said, “PVX108 is the first therapy designed to precisely target the root cause of peanut allergy. This study shows that PVX108 could meaningfully impact peanut allergy in young children. It also provided encouraging evidence that durable clinical benefits can be achieved with a T cell-targeting peptide immunotherapy. This raises the exciting possibility of being able to offer patients hope for a fundamentally different future; one where altering the course of disease becomes possible, rather than simply suppressing allergic reactions.”
Aravax’s Phase 2 clinical trial of PVX108 (AVX-201: NCT05621317) was conducted across 14 trial sites in the US and Australia. Trial participants with peanut allergy were enrolled into two cohorts: a pilot safety cohort (n=24) in adolescents aged 12-17 years (Cohort 1); and a primary efficacy and safety cohort in children aged 4 to 11 years (n= 71) (Cohort 2). The trial involved a randomized, double-blind, placebo-controlled treatment period to evaluate efficacy and safety of PVX108 given monthly by intradermal administration. In Cohort 2, two dose levels (5 nmol, 50 nmol) were evaluated against placebo over a 12-month (M12) period. Efficacy was measured using a double-blind placebo-controlled food challenge following the PRACTALL guidelines.
Full topline results will be presented by Brian P. Vickery, MD, Chief of Allergy and Immunology at Children’s Healthcare of Atlanta and Professor and Vice-Chair of Pediatric Clinical Research at Emory University School of Medicine at 16:30 MST on 14 November 2026 in a Distinguished Industry and Late-breaking Oral Abstracts Session at the Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Phoenix, AZ. The abstract can be found here: Abstract ID,7001; Presentation ID LBA005.
Dr Vickery said, “There is a critical need for new approaches to the treatment of peanut allergy, especially in younger children. Peanut allergy is a growing and serious problem for those living with allergies and their families. I am excited that this study has delivered compelling early evidence that PVX108 could deliver clinically meaningful impact in peanut allergy. These data show that once-monthly administration of PVX108 may offer the possibility of retraining the immune response to peanuts without burdensome precautions and, as such, have a longer-term positive impact on the course of allergic disease. If confirmed by larger studies, this would represent a significant leap forward for the food allergy field.”
Key results at M12 (Cohort 2: 4 to11 year-old population):
- 96% (68/71) of participants completed treatment and the M12 primary endpoint food challenge. There were no withdrawals due to study treatment.
- The trial met its primary efficacy endpoint. There was a statistically significant difference in the increase in maximum tolerated dose of peanut from baseline to M12 observed between PVX108 50nmol (n=23) and placebo (n=24) in the intent to treat analysis set (2.4-fold vs 1.2-fold change in least squares geometric mean, respectively).
- A statistically significant reduction in the severity of food challenge reactions was observed at M12 in the PVX108 50nmol group compared to placebo. At baseline, all participants experienced moderate or severe reactions at the dose of peanut to which they reacted (baseline reactive dose). At M12, more than two thirds (67%) of the adverse reactions to the baseline reactive dose of the food challenge were graded zero or mild in the PVX108 group vs 35% graded zero or mild in the placebo group.
- At M12, 39.4% of participants treated with PVX108 50nmol tolerated a cumulative dose of ≥ 443mg peanut protein vs 16.7% in the placebo group: A cumulative tolerated dose of 443mg peanut equates to a maximum tolerated dose level of 300mg, a reactive (eliciting) dose level of 600mg, or a cumulative reactive dose of 1043mg for the food challenge used in this study; One peanut contains approximately 250-300mg peanut protein.
- A clear dose-dependent improvement was observed for child-reported outcomes relating to the emotional impact of living with a food allergy at M12 which reached significance in the PVX108 50nmol group compared to placebo.
- Peanut skin prick test reactions were also significantly improved following PVX108 treatment compared to placebo.
- PVX108 was well-tolerated: No treatment-related allergic adverse events, including anaphylaxis, or treatment-related serious adverse events were reported for either dose of PVX108. Treatment related adverse events were only reported in 6 participants in total, 1 (4.2%) in the placebo group, 2 (8.3%) in the 5 nmol PVX108 group, and 3 (13%) in the 50 nmol PVX108 group. No treatment related event was more than grade 2 in severity and the most frequently reported of these were local administration site reactions.
- These results were further strengthened by the consistent dose-response relationship observed across a range of endpoints at M12: the treatment signal at the 50nmol dose level generally being stronger than at the 5nmol dose level.
Following a further six-month treatment-free period, a follow up food challenge was conducted (i.e. at month 18, [M18]). This showed evidence of maintenance or improvement in clinical effects at M18 compared to M12, indicating the disease-modifying potential of PVX108. Encouragingly, 59 of the 68 completers (87%) elected to continue in a 12-month open-label extension study with results anticipated in H2 2027.
Dr Sara Prickett, CSO, Aravax said, “We are excited to see the positive results from this study and I would like to recognise the contribution of everyone involved in the trial within Aravax, our scientific and clinical network, the investigators in the trial and, most importantly the young people who participated and their families. They, and others living with peanut allergy, are the drivers of our commitment to PVX108 and its continued development.”
Dr Pascal Hickey, CEO, Aravax added, “These Phase 2 study results provide a very solid foundation for our planned future clinical program for PVX108 and our wider pipeline.”
The data will also be presented in Europe by Associate Professor Edwin Kim, Pediatrics Division Chief, Pediatric Allergy and Immunology, University of North Carolina and Director, Food Allergy Initiative (UNC FAI), in an oral presentation during 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) meeting in Utrecht, Netherlands on Friday 20 November, Session FT01, 10:30-12:00 CET.
Caption: (left) Dr Sara Prickett, CSO Aravax, (right) Dr Chris Smith, Chair Aravax and Partner at Brandon Capital, (centre), Dr Pascal Hickey CEO Aravax
Caption: Dr Brian P. Vickery
About Aravax
Aravax is a clinical stage biotechnology company focused on revolutionising the treatment of food allergies with next-generation, disease-modifying immunotherapies which aim to be safer and more convenient than existing approaches.
Aravax’s proprietary platform generates peptides designed to precisely retrain the immune system and restore the body’s ability to tolerate food allergens, with minimal risk to patients of significant treatment-induced acute allergic reactions, including anaphylaxis. The company’s lead product, PVX108 for the treatment of peanut allergy, has delivered positive results in an international Phase 2 safety and efficacy trial. PVX108 has been awarded FDA Fast Track designation for the treatment of peanut allergy. Aravax is also developing a pipeline of products to address additional food allergy indications.
An international company with entities in Australia and the UK, Aravax’s syndicate of leading international and Australian investors includes Novartis Venture Fund, Brandon Capital, Tenmile, Innovation Victoria, Uniseed and UniSuper.
For more information visit: www.aravax.com.au
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