Aravax’s PVX108 immunotherapy met its primary endpoint in a Phase 2 trial, increasing peanut tolerance in children with peanut allergy.

Australian biotechnology company Aravax has reported positive Phase 2 results for its investigational peanut allergy treatment PVX108, with the monthly immunotherapy increasing peanut tolerance in children compared with placebo.

The trial met its primary efficacy endpoint, demonstrating a statistically significant difference in the increase in maximum tolerated peanut dose after 12 months of treatment.

PVX108 is a peptide-based immunotherapy designed to target specific immune responses associated with peanut allergy. Administered monthly by intradermal injection, the treatment aims to retrain the immune system to tolerate peanut proteins while minimising allergic reactions during treatment.

The Phase 2 study (AVX-201; NCT05621317) involved 95 participants across 14 sites in the US and Australia. It included a pilot safety cohort of 24 adolescents aged 12–17 and an efficacy and safety cohort of 71 children aged 4–11.

The main efficacy cohort received either 5 nmol or 50 nmol of PVX108, or placebo, during a 12-month randomised, double-blind, placebo-controlled treatment period.

Efficacy was assessed through a double-blind placebo-controlled food challenge conducted according to PRACTALL guidelines.

(left) Dr Sara Prickett, CSO Aravax, (right) Dr Chris Smith, Chair Aravax and Partner at Brandon Capital, (centre), Dr Pascal Hickey CEO Aravax

Peanut tolerance increased following monthly treatment

In the primary efficacy analysis, children receiving the 50 nmol dose achieved a 2.4-fold change in maximum tolerated peanut dose from baseline to month 12, compared with a 1.2-fold change in the placebo group.

The study also found a statistically significant reduction in the severity of reactions during food challenges among children receiving the higher PVX108 dose.

At baseline, all participants experienced moderate or severe reactions at their individual reactive peanut dose. By month 12, 67% of reactions at this baseline dose in the 50 nmol group were graded as zero or mild, compared with 35% in the placebo group.

Additionally, 39.4% of children receiving the higher dose tolerated a cumulative peanut protein dose of at least 443 mg, compared with 16.7% of those receiving placebo.

The findings also extended beyond the food challenge results. Children receiving PVX108 reported improvements in the emotional impact of living with food allergy, with a dose-dependent effect reaching statistical significance in the 50 nmol group compared with placebo.

Peanut skin prick test reactions also improved significantly following treatment.

Pascal Hickey, CEO of Aravax, said: “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.”

No treatment-related allergic reactions reported

PVX108 demonstrated a favourable safety and tolerability profile during the study.

No treatment-related allergic adverse events, including anaphylaxis, or treatment-related serious adverse events were reported in either treatment group.

Treatment-related adverse events occurred in six participants across the study groups. These included one participant receiving placebo, two receiving the 5 nmol dose and three receiving the 50 nmol dose. None was more severe than grade 2, with local administration site reactions among the most frequently reported events.

Of the 71 children enrolled in the primary efficacy cohort, 68 (96%) completed treatment and the month 12 food challenge. No participants withdrew because of study treatment.

Effects maintained after treatment stopped

A follow-up food challenge at month 18, after six months without treatment, provided further evidence of maintained or improved clinical effects compared with month 12.

Aravax said the findings suggest PVX108 could have disease-modifying potential, although further clinical research will be needed to establish the durability of its effects.

The company also reported that 59 of the 68 children who completed the initial treatment period elected to enter a 12-month open-label extension study, with results expected in the second half of 2027.

The full Phase 2 results will be presented by Brian Vickery, chief of allergy and immunology at Children’s Healthcare of Atlanta, at the American College of Allergy, Asthma and Immunology (ACAAI) annual scientific meeting in Phoenix on 14 November 2026.

The findings will also be presented at a European allergy meeting in Utrecht, Netherlands, on 20 November.

Vickery said: “There is a critical need for new approaches to the treatment of peanut allergy, especially in younger children.”

He added: “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.”

PVX108 has received FDA Fast Track designation for peanut allergy, although it remains investigational and is not approved for clinical use.