Allergy Therapeutics announced the commencement of subcutaneous dosing of peanut allergic patients in the Phase I/IIa PROTECT trial evaluating its novel virus-like particle (VLP)-based peanut allergy vaccine candidate ("VLP Peanut"). Patients allergic to peanuts have previously undergone skin-prick testing in part A of the PROTECT trial. Following an external safety review committee (SRC), it was determined that no safety signals had been observed and it was safe to proceed with incremental subcutaneous dosing in healthy subjects in the Phase I stage and in peanut allergic patients in the Phase IIa part of the trial.

The PROTECT trial is being conducted in both healthy volunteers and peanut allergic patients and consists of Part A and Part B. Part A involves subcutaneous immunotherapy (SCIT) dosing in healthy volunteers (Group A1) and skin-prick testing in peanut allergic patients (Group A2), the latter of which was completed in April 2023. Part B of the clinical trial is double-blind, placebo-controlled and 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 dose as currently planned.