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Advancement to final phase of PROTECT trial
Advancement to final phase of PROTECT trial.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n\n\nAllergy Therapeutics plc\n(\"Allergy Therapeutics\", \"ATL\" or the \"Group\")\n \nAllergy Therapeutics advances to the final phase of treatment in Phase I/IIa VLP Peanut PROTECT trial and announces publication of mechanism of action data\n \n· Healthy volunteers now receiving highest doses with no safety signals observed\n· Third cohort of peanut allergic patients progressing through therapeutic dose range\n· New peer-reviewed publication in Journal of Allergy and Clinical Immunology validates mechanism of action\n \n27 March 2025 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy immunotherapies, today announces that its VLP Peanut Phase I/IIa PROTECT trial has entered the final phase of treatment, with healthy volunteers progressing to the highest dose levels and no safety signals observed to date.\n \nAs part of this phase, the final cohort of healthy volunteers is now receiving subcutaneous doses of VLP Peanut, the Group's innovative, short-course peanut allergy vaccine candidate, beyond the expected therapeutic dose level to establish a strong safety margin. Meanwhile, the third of four planned cohorts of peanut-allergic patients is progressing through dose escalation, also including levels beyond the anticipated therapeutic range. These data will supplement previously reported biomarker efficacy findings observed at lower cumulative doses, strengthening the understanding of treatment response at higher doses.\n \nResults from the current patient cohort will also be key in defining the optimal dose range for the upcoming Phase IIb study while reinforcing confidence in the treatment's safety profile. Both healthy volunteers and peanut-allergic patients have progressed through their initial dose escalation, and, following a safety review, the committee has recommended advancing to the second of three planned dose increases for each cohort.\n \nIn addition, Allergy Therapeutics announces the publication of a new paper in the Journal of Allergy and Clinical Immunology (JACI), which evaluates the beneficial tolerogenic properties and immunological reactivity of VLP Peanut.\n \nPeanut allergy remains a growing public health concern, particul...