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Primary Safety Endpoint Met in PROTECT trial
Allergy Therapeutics PLC announced that its Phase I/IIa PROTECT trial has met its primary safety endpoint, with preliminary data from 48 participants showing that a 2000-fold increase in the dose of VLP Peanut was safe and well-tolerated. The trial completed final dosing at the highest planned treatment dose, and data from a second interim biomarker analysis in peanut-allergic patients receiving these highest doses is anticipated in Q1 2026. Preparations are underway for a Phase IIb trial, informed by the safety and efficacy data from the PROTECT study. Disclaimer*
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n\n\n\nAllergy Therapeutics plc\n(\"Allergy Therapeutics\", \"ATL\" or the \"Group\")\n \nPROTECT Phase I/IIa trial meets primary safety endpoint at highest planned dose\n \n· PROTECT trial achieves final dosing of the minimum anticipated number of patients at the highest planned treatment dose\n· Preliminary safety data from 48 participants demonstrate that a 2000-fold increase in dose of VLP Peanut has been safe and well tolerated\n· Data from the second interim biomarker analysis in peanut-allergic patients receiving the highest doses is expected in Q1 2026, following the previously announced initial interim analysis data from lower doses\n \n09 December 2025 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy immunotherapies, today announces that its Phase I/IIa PROTECT trial has completed final dosing of the minimum required number of patients at the highest planned treatment dose, meeting the trial's primary safety endpoint. Preliminary safety data from 48 participants demonstrate that a 2000-fold increase in dose from the starting dose has been safe and well tolerated, including in both peanut-allergic patients and healthy participants.\n \nAs previously reported, a benign safety profile of VLP Peanut is supported by the observed dose-dependent reduction in wheal size following skin prick testing for the two lowest doses evaluated. In addition, peanut-allergic patients showed a strong immune-protective dose response in biomarkers at low cumulative doses, with dose-dependent suppression of basophil activation and a dose-dependent increase in protective Ara h2 IgG, aligned with a dose-dependent reduction in IgE binding to B-cells.\n \nData from healthy participants support the proposed mechanism of action of VLP Peanut. In addition, preliminary blinded biomarker data collected three months after last dosing of peanut allergic patients indicate a sustained biomarker response. The Company intends to carry out a second interim analysis in peanut-allergic patients receiving the highest doses in due course.\n \nThe trial is currently progressing to deliver the planned group unblinded skin prick test and biomarker results, together with longer-term biom...