Biotechnology company Allergy Therapeutics plc (AIM: AGY) on Wednesday reported positive biomarker results from its Phase I/IIa PROTECT trial of VLP Peanut, following the achievement of the study's primary safety endpoint.

The trial demonstrated a consistent immunomodulatory response in peanut-allergic subjects, with increasing doses of VLP Peanut linked to significant reductions in basophil sensitivity to peanut and Ara h2 versus baseline. At the highest dose, reductions reached 376% for peanut and 489% for Ara h2 compared with placebo, both achieving statistical significance.

Further biomarker analysis showed a statistically significant, dose-dependent decrease in Ara h2 binding to effector B-cells, alongside a clear increase in Ara h2-specific IgG levels across dose groups. Skin prick testing also indicated an absolute reduction in wheal diameter one month post-treatment, contrasting with a slight increase in the placebo group.

The PROTECT trial completed final dosing in December 2025 and evaluated safety, tolerability and preliminary efficacy of the short-course immunotherapy candidate. No significant safety concerns were identified despite a 2,000-fold dose escalation.

Allergy Therapeutics said the results support progression towards a Phase IIb trial, with dose selection informed by the combined safety and efficacy data.