UK-based Allergy Therapeutics has commenced dosing of the second part of a Phase I/IIa trial of its subcutaneous virus-like particle (VLP)-based peanut allergy vaccine VLP Peanut.

The PROTECT trial (NCT05476497) will include two parts with the candidate being investigated in both healthy volunteers and peanut-allergic patients, to evaluate the safety and tolerability of the candidate, as well as investigating preliminary efficacy signals.

Part A, which was completed in April 2023, was an open-label trial involving two cohorts. The first cohort of healthy volunteers was given subcutaneous immunotherapy (SCIT). The second cohort included peanut-allergic patients with skin-prick testing.

No safety signals were observed in the healthy volunteers, with a safety committee determining it as being safe to proceed in the trial with peanut-allergic patients.

Part B is a double-blind, placebo-controlled, proof-of-concept trial and has commenced in subjects with peanut allergy at 10 clinical trial sites in the US. The company plans to enrol 36 peanut-allergic patients.

Patients will receive three escalating doses of the candidate over three separate dosing days.

The ClinicalTrials.gov listing estimates that the completion of the trial will be in October 2025.

Allergy Therapeutics CEO Manuel Llobet said: “This is a key milestone in our journey to offer transformative outcomes to patients living with peanut allergies.”

Peanut allergy landscape

Peanut allergy is one of the most common food allergies with more than 1.6 million affected in the US. According to GlobalData analysis, the market size for peanut allergy in 2023 was approximately $6.1bn.

There is a high unmet need for safe and effective treatments for peanut allergy to both improve quality of life and provide peace of mind for caregivers. There is also a need for treatments that can be used in younger children, as currently there are limited options for children under the age of four.

According to GlobalData’s Pharmaceutical Intelligence Centre, the pipeline for peanut allergy includes 57 drugs.

GlobalData is the parent company of the Clinical Trials Arena.