Allergy Therapeutics PLC has initiated subcutaneous dosing of peanut allergic patients in the Phase I/IIa PROTECT trial for its virus-like particle (VLP)-based peanut allergy vaccine candidate, VLP Peanut. The first patient received subcutaneous dosing with no safety signals observed, marking the start of the clinical proof of concept phase using biomarkers to assess preliminary efficacy. The trial has progressed to the Phase IIa part, with no safety signals observed in the cohorts treated to date.

The PROTECT trial involves subcutaneous immunotherapy dosing in healthy volunteers and skin-prick testing in peanut allergic patients. Part B of the trial, which is double-blind and placebo-controlled, has commenced in subjects with peanut allergy at multiple clinical trial sites in the US. Up to 36 peanut-allergic subjects will be enrolled in Part B of the clinical trial, should the dosing advance to the highest planned dose.

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, expressed excitement about gathering data supportive of efficacy using biomarker technology aligned with recent FDA workshop thinking on demonstrating efficacy in clinical trials. The company looks forward to the complete results of the trial and continues to work towards the required planning for the phase II.

Allergy Therapeutics is an international commercial biotechnology company specializing in the treatment and diagnosis of allergic disorders. The Group's broad pipeline of products in clinical development includes vaccines for grass, tree, house dust mite, and peanut. For more information about the PROTECT trial, visit ClinicalTrials.gov under the identifier NCT05476497.

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