REG - Allergy Therapeutics - Primary Safety Endpoint Met in PROTECT trial

Allergy TherapeuticsAnnouncement

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RNS Number : 7153K  Allergy Therapeutics PLC  09 December 2025

Allergy Therapeutics plc

("Allergy Therapeutics", "ATL" or the "Group")

 

PROTECT Phase I/IIa trial meets primary safety endpoint at highest planned
dose

 

·      PROTECT trial achieves final dosing of the minimum anticipated
number of patients at the highest planned treatment dose

·      Preliminary safety data from 48 participants demonstrate that a
2000-fold increase in dose of VLP Peanut has been safe and well tolerated

·      Data from the second interim biomarker analysis in
peanut-allergic patients receiving the highest doses is expected in Q1 2026,
following the previously announced initial interim analysis data from lower
doses

 

09 December 2025 Allergy Therapeutics (AIM: AGY), the fully integrated
commercial biotechnology company specialising in allergy immunotherapies,
today announces that its Phase I/IIa PROTECT trial has completed final dosing
of the minimum required number of patients at the highest planned treatment
dose, meeting the trial's primary safety endpoint. Preliminary safety data
from 48 participants demonstrate that a 2000-fold increase in dose from the
starting dose has been safe and well tolerated, including in both
peanut-allergic patients and healthy participants.

 

As previously reported, a benign safety profile of VLP Peanut is supported by
the observed dose-dependent reduction in wheal size following skin prick
testing for the two lowest doses evaluated. In addition, peanut-allergic
patients showed a strong immune-protective dose response in biomarkers at low
cumulative doses, with dose-dependent suppression of basophil activation and a
dose-dependent increase in protective Ara h2 IgG, aligned with a
dose-dependent reduction in IgE binding to B-cells.

 

Data from healthy participants support the proposed mechanism of action of VLP
Peanut. In addition, preliminary blinded biomarker data collected three months
after last dosing of peanut allergic patients indicate a sustained biomarker
response. The Company intends to carry out a second interim analysis in
peanut-allergic patients receiving the highest doses in due course.

 

The trial is currently progressing to deliver the planned group unblinded skin
prick test and biomarker results, together with longer-term biomarker and
scheduled safety assessments for up to one year after last dosing.

 

Preparations are also underway for the Phase IIb trial, with the doses of VLP
Peanut being informed by the combined safety and efficacy information
generated in the PROTECT trial.

 

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented:
""The PROTECT trial has now reached a key regulatory milestone with the
primary safety endpoint achieved at the highest planned treatment dose. Safety
and tolerability at these dose levels remain supportive, reinforcing our
confidence in the short-course approach underpinning VLP Peanut.

 

"As we move into the final stages of follow-up and biomarker assessment, our
focus is on translating these data into the next phase of clinical
development. We thank all participants, investigators and clinical teams
involved in the study."

 

 

More information about the PROTECT trial can be found on ClinicalTrials.gov
(https://clinicaltrials.gov/ct2/home)  under the identifier NCT05476497
(https://clinicaltrials.gov/ct2/show/NCT05476497?term=NCT05476497&draw=2&rank=1)
.

 

This announcement contains inside information for the purposes of the UK
Market Abuse Regulations.

 

 

- ENDS -

 

 

Allergy Therapeutics

Manuel Llobet, Chief Executive Officer

Shaun Furlong, Chief Financial Officer

+44 (0)1903 845 820

 

Cavendish Capital Markets Limited (Nominated Adviser and Broker)

Geoff Nash /Giles Balleny/ Seamus Fricker

Nigel Birks - Life Science Specialist Sales

+44 (0)20 7220 0500

 

ICR Healthcare

Mary-Jane Elliott / David Daley / Davide Salvi

+44 (0)20 3709 5700

allergytherapeutics@icrhealthcare.com
(mailto:allergytherapeutics@icrhealthcare.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 immunotherapies 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 (http://www.allergytherapeutics.com) .

 

About the PROTECT Trial

The trial is evaluating the safety and tolerability, and exploring preliminary
proof of efficacy, of the Group's innovative, short-course peanut allergy drug
candidate, VLP Peanut.

 

The PROTECT trial, across multiple clinical trial sites in the US, is being
conducted in both healthy subjects and peanut allergic patients and consists
of Part A and Part B. Part A involved subcutaneous immunotherapy (SCIT) dosing
in healthy subjects (Group A1) and skin-prick testing in peanut allergic
patients (Group A2). Part B of the clinical trial is double-blind,
placebo-controlled and in patients with peanut allergy.

 

 

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