PVX108 is an experimental treatment for peanut allergy that uses synthetic peptides to retrain the immune system to tolerate peanut. Its maker, Aravax, announced on 12 November 2026 — 13 November in Australia, where the company is based — that the treatment met its main goal in a Phase 2 clinical trial in children. Children given the higher dose could tolerate significantly more peanut after 12 months of monthly injections than children given a placebo, and the benefit was still present six months after treatment stopped. PVX108 is not approved for use, and the results are preliminary company-reported findings from a small trial.

Peanut allergy is one of the most common and most feared food allergies in children, because even a small amount of peanut can trigger a severe reaction. There is no cure. PVX108 aims for a different route: a monthly injection under the skin, using peptides — short chains of amino acids based on peanut proteins — designed to teach the immune system to tolerate peanut while minimising the allergic reactions that treatment itself can cause.

What did the trial find?

The trial, known as AVX-201 and registered as NCT05621317, was randomised, double-blind and placebo-controlled, and ran at 14 trial sites in the United States and Australia. Its primary efficacy group was 71 children aged 4 to 11, who received either a low dose of PVX108 (5 nanomoles), a higher dose (50 nanomoles), or a placebo, given monthly by injection into the skin over 12 months.

After 12 months, the trial met its primary endpoint. In the higher-dose group, the maximum tolerated dose of peanut — the largest amount a child could eat in a supervised food challenge before reacting — rose 2.4-fold from the start of the trial, compared with a 1.2-fold rise in the placebo group, a statistically significant difference. In practical terms, 39.4 percent of children on the higher dose tolerated a cumulative dose of 443 milligrams or more of peanut protein, roughly the protein in one and a half to two peanuts, compared with 16.7 percent of children on placebo.

Almost all the children finished the trial: 96 percent, or 68 of 71, completed treatment and the 12-month food challenge, and no child withdrew because of the treatment. Aravax described the safety and tolerability profile as highly favourable. Children on the treatment also reported a significant reduction in the emotional impact of their allergy compared with those on placebo, one of the trial's secondary measures.

How does PVX108 work?

PVX108 is an immunotherapy, which means it tries to change how the immune system responds to peanut rather than simply treating reactions after they happen. In peanut allergy, the immune system mistakes peanut proteins for a threat and produces an exaggerated response, including the release of histamine, which drives symptoms from hives to anaphylaxis. The peptides in PVX108 are designed to present the immune system with fragments of peanut protein in a form that encourages tolerance, without carrying the full structure that triggers a strong allergic reaction.

The treatment is given as a monthly injection into the skin, known as intradermal administration. It has been awarded Fast Track designation by the United States Food and Drug Administration, a status given to treatments for serious conditions where early evidence suggests they may address an unmet medical need. Fast Track is not an approval; it is a process that allows closer contact with the regulator as development continues.

Who took part in the trial?

The trial enrolled two groups. Cohort 1 was a pilot safety group of 24 adolescents aged 12 to 17. Cohort 2, the main efficacy and safety group, was 71 children aged 4 to 11. In Cohort 2, children were divided between the two dose levels and placebo: the published results compare 23 children on the 50-nanomole dose with 24 on placebo. The trial ran across 14 sites in the US and Australia, and the treatment period lasted 12 months, followed by further food challenges six months after treatment ended.

At the 18-month point, six months after the last injection, the improvements in peanut tolerance were maintained and in some cases increased, according to the company and independent coverage of the results. That pattern, if confirmed, would suggest the treatment changes the underlying allergy rather than only suppressing it during treatment, though that claim needs much more evidence.

What happens next?

The full results will be presented by Dr Brian P. Vickery, chief of allergy and immunology at Children's Healthcare of Atlanta and professor at Emory University School of Medicine, at 16:30 Mountain Standard Time on 14 November 2026, in a late-breaking oral session at the annual scientific meeting of the American College of Allergy, Asthma and Immunology in Phoenix, Arizona.

Most of the children who finished the trial chose to continue: 87 percent enrolled in a 12-month open-label extension, in which all participants receive the treatment, with further results expected in the second half of 2027. A larger Phase 3 trial, which would be needed before regulators could consider approval, has not yet been announced. Until then, PVX108 remains investigational, and it is not available outside clinical trials.

What this does not mean

The results should not be read as a cure, and they do not mean children with peanut allergy can now eat peanuts. The children who benefited could tolerate around 443 milligrams of peanut protein in a supervised hospital challenge — roughly one and a half to two peanuts — which is a buffer against accidental exposure, not a licence to eat peanut freely. The trial was small, with only 23 children on the higher dose in the main comparison, and the results so far are topline figures announced by the company, not yet published in a peer-reviewed journal. Families should not change how they manage a peanut allergy on the basis of this announcement, and anyone interested in trials should speak to their allergy specialist.

Frequently asked questions

Is PVX108 available now? No. It is an investigational treatment that has completed Phase 2 testing. It is not approved by any regulator, and it is not available outside clinical trials.

How is PVX108 given? As a monthly injection into the skin, known as intradermal administration, over a 12-month course in the trial.

How is it different from oral immunotherapy? Oral immunotherapy involves eating gradually increasing amounts of peanut protein, usually every day. PVX108 instead uses synthetic peptides based on peanut proteins, given as a monthly injection, with the aim of retraining the immune system while minimising treatment-induced allergic reactions.

What does 443 milligrams of peanut protein mean? It is roughly the protein content of one and a half to two peanuts, and it was the threshold dose that 39.4 percent of children on the higher dose could tolerate in a supervised food challenge, against 16.7 percent on placebo.

Did the benefit last after treatment stopped? According to the company, improvements in tolerance were maintained or increased six months after treatment ended, at the 18-month follow-up. That finding still needs confirmation in larger trials.

Sources: Aravax announcement via GlobeNewswire, 12 November 2026; SnackSafely coverage of the Phase 2 results, 12 November 2026.