Allergy Therapeutics PLC has announced the initiation of subcutaneous dosing of peanut allergic patients in the Phase I/IIa PROTECT trial for its VLP Peanut allergy vaccine candidate. 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 dose escalation in healthy subjects to pave the way for similar strengths in peanut allergic patients.

The PROTECT trial, conducted in both healthy volunteers and peanut allergic patients, consists of Part A and Part B. Part A involved subcutaneous immunotherapy dosing in healthy volunteers and skin-prick testing in peanut allergic patients, with no safety signals observed. Part B, a double-blind, placebo-controlled phase, has commenced in peanut allergic subjects at multiple clinical trial sites in the US.

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.

The Group will announce trial updates as appropriate, and more information about the PROTECT trial can be found on ClinicalTrials.gov under the identifier NCT05476497. This announcement contains inside information for the purposes of Article 7 of the UK Market Abuse Regulations. For further information, interested parties can contact Allergy Therapeutics or Panmure Gordon (Nominated Adviser and Broker).

This update signifies a significant step forward in Allergy Therapeutics' efforts to offer transformative outcomes to patients living with peanut allergies, and the company is poised to continue advancing its innovative VLP Peanut allergy vaccine candidate through the PROTECT trial.