Allergy Therapeutics has announced the progression of patient cohorts in its Phase I/IIa VLP Peanut PROTECT Trial. The trial is evaluating the maximum safe and tolerated dose of the Group's peanut allergy vaccine candidate and includes assessment of biomarker efficacy in peanut allergic patients. The first cohort of peanut allergic patients has completed subcutaneous dosing with three incremental dose increases, with no relevant safety or tolerability findings. Additionally, the third cohort of healthy subjects has completed dosing without relevant safety or tolerability issues, representing a 400-fold dose increase from the first dose administered.

The company is preparing for the PROTECT trial to progress to the last cohort in healthy subjects and dose escalation to similar high strengths in peanut allergic patients with biomarker analysis of efficacy included. The completion of new cohorts of healthy subjects and peanut allergic patients who have received increasing dose strengths of its novel virus-like particle (VLP)-based peanut allergy vaccine candidate ("VLP Peanut") has been announced.

The CEO of Allergy Therapeutics, Manuel Llobet, expressed optimism about the safety and tolerability data from the latest cohorts in the PROTECT trial, stating that it provides a solid basis for the design of the upcoming Phase IIb study. The trial continues to progress, aiming to generate the first biomarker-led efficacy data among higher-dose peanut allergic patients in the next cohorts of the trial.

The PROTECT trial is being conducted in both healthy subjects and peanut allergic patients and consists of Part A and Part B. Part A involves subcutaneous immunotherapy (SCIT) dosing in healthy subjects (Group A1) and skin-prick testing in peanut allergic patients (Group A2). The Group's peanut allergy vaccine candidate, VLP Peanut, is a next-generation peanut allergy immunotherapy, and the completion of these patient cohorts marks a significant step forward in the development of this potential treatment.