Progression of patient cohorts in PROTECT Trial

Allergy Therapeutics plc

("Allergy Therapeutics" or "the Group")

Allergy Therapeutics announces progression through patient cohorts in Phase I/IIa VLP Peanut PROTECT Trial

-       First cohort of peanut allergic patients in Phase I/IIa VLP Peanut PROTECT trial completes subcutaneous dosing with three incremental dose increases and no relevant safety or tolerability findings

-       Third cohort of healthy subjects completes dosing without relevant safety or tolerability issues representing a 400-fold dose increase from the first dose administered

-       Preparations underway for PROTECT trial to progress to last cohort in healthy subjects and dose escalation to similar high strengths in peanut allergic patients with biomarker analysis of efficacy included

10 June 2024 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces 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").

A next-generation peanut allergy immunotherapy

The ongoing Phase I/IIa VLP Peanut PROTECT 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.

Patients who are allergic to peanuts had previously completed skin-prick testing in the PROTECT trial and, following the announcement on 12 March 2024 that the first peanut allergic patient had received subcutaneous dosing of the candidate vaccine, that patient cohort has now completed three incremental dose levels over 2 months with no safety signals observed.

Healthy subjects in the PROTECT trial have now received a 400-fold dose increase of VLP Peanut, providing strong confidence that the VLP technology within the vaccine candidate is safe and well tolerated at high cumulative doses. This is essential for further clinical development of VLP Peanut as the external safety review committee agreed that the doses administered so far have been safe and well tolerated and dose increments in next cohorts can proceed as planned to similarly high doses in peanut allergic patients and to establish the dose range to be considered for the upcoming Phase IIb study.

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "The promising safety and tolerability data from the latest cohorts in the PROTECT trial of our peanut allergy vaccine candidate are welcomed, providing a solid basis for the design of our upcoming Phase IIb study. Ahead of that, the PROTECT trial continues apace as we look to generate the first biomarker-led efficacy data, among higher-dose peanut allergic patients in the next cohorts of the trial."

More information about the PROTECT trial can be found on ClinicalTrials.gov under the identifier NCT05476497.

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For further information, please contact:

Allergy Therapeutics

Manuel Llobet, Chief Executive Officer

Shaun Furlong, Chief Financial Officer

+44 (0)1903 845 820

Panmure Gordon (Nominated Adviser and Broker)

Emma Earl, Freddy Crossley, Mark Rogers, Corporate Finance

Rupert Dearden, Corporate Broking

+44 (0)20 7886 2500

ICR Consilium

Mary-Jane Elliott / David Daley / Davide Salvi

+44 (0)20 3709 5700

allergytherapeutics@consilium-comms.com

Notes for editors:

About Allergy Therapeutics

Allergy Therapeutics is an international commercial biotechnology company, headquartered in the UK, focussed on the treatment and diagnosis of allergic disorders, including aluminium free immunotherapy vaccines that have the potential to cure disease. The Group sells proprietary and third-party products from its subsidiaries in nine major European countries and via distribution agreements in an additional ten countries. For more information, please see www.allergytherapeutics.com.

About the PROTECT 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 latter of which was completed in April 2023. 

Part B of the clinical trial is double-blind, placebo-controlled and has commenced in patients with peanut allergy at multiple clinical trial sites in the US. Up to 36 peanut-allergic patients will be enrolled in Part B of the clinical trial, should the dosing advance to the highest dose as currently planned.