Phase 2 Clinical Trials

AVX-201

AVX-201 is a randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the safety and efficacy of PVX108 given once monthly by intradermal administration in adolescent and children participants with peanut allergy.

The AVX-201 trial (NCT05621317) was conducted over a 12-month period across a total of 14 trial sites, eight in United States and six in Australia.

Clinical Trial

Trial participants with peanut allergy were enrolled into two groups. Cohort 1 was a safety cohort of 24 adolescents aged 12-17 years. Cohort 2 was the main efficacy and safety group of 71 children aged 4 to 11 years. In Cohort 2, two dose levels (5 nmol or 50 nmol) were evaluated against placebo over a 12-month period. Efficacy was measured using a double-blind placebo-controlled food challenge following the PRACTALL guidelines.

During the trial participants were monitored for safety and blood samples were collected for biological and immunological studies.

Clinical Trial Results

PVX108 immunotherapy achieved its primary endpoint. PVX108 increased the maximum tolerated dose of peanut compared to placebo following a convenient, once-monthly treatment course over 12 months, while demonstrating a favorable 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.

Six months after participants received their last PVX108 treatment, there was evidence of a maintenance effect indicating its potential for disease-modification.

AVX-201 Extension Studies

A PVX108 open-label extension study is ongoing in children with 12-month results anticipated in H2 2027.

Learn more about the Phase 2 clinical trial design Learn more about the Phase 2 clinical trial results

PVX108 is an investigational drug product
PVX108 is undergoing clinical studies to evaluate the safety and effectiveness in humans. It has not received marketing authorization or approval by any regulatory agency, including the US Food and Drug Administration, or the Australian Therapeutic Goods Administration and the European Medicines Agency.