REG - Allergy Therapeutics - Further progress in Phase I/IIa PROTECT trial

Allergy TherapeuticsAnnouncement

Thu 07:00

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RNS Number : 5683D  Allergy Therapeutics PLC  16 October 2025

 

 

Allergy Therapeutics plc

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

 

 

Allergy Therapeutics announces further positive progress in Phase I/IIa
PROTECT trial evaluating safety and tolerability of short-course peanut
allergy vaccine candidate

 

·    Dosing in healthy volunteers completed; VLP Peanut well tolerated up
to the highest planned dose

·    Final cohort of peanut allergic patients with multiple escalating
doses of VLP Peanut/placebo progressing as planned with supportive safety and
tolerability profile

·    Encouraging dose-dependent biomarker responses and consistent safety
data to inform Phase IIb dose selection

 

16 October 2025 Allergy Therapeutics (AIM: AGY), the fully integrated
commercial biotechnology company specialising in allergy immunotherapies,
today announces further positive progress in its Phase I/IIa PROTECT trial,
evaluating the safety and tolerability, and exploring preliminary proof of
efficacy, of its innovative, short-course peanut allergy vaccine candidate,
VLP Peanut, in healthy and peanut allergic adult subjects.

 

No relevant safety signals were identified across each of the trial's cohorts,
which supports the safety profile of VLP Peanut. This is achieved by
disguising the major peanut allergen (Ara h2) on the surface of the
nanoparticle used in the vaccine candidate, reducing its allergenicity and
inducing a favourable pro-tolerogenic immune response.

 

In earlier stages of the trial, as previously announced, peanut allergic
patients treated with ascending concentrations of the vaccine candidate showed
a marked reduction in wheal size versus placebo using a whole peanut extract
skin prick test. The study subsequently progressed to include both healthy
volunteers and peanut allergic patients who were dosed subcutaneously with
further ascending concentrations of VLP Peanut, aiming to determine the
maximum tolerated dose.

 

Healthy cohorts have now completed dosing at the maximum intended levels, with
no dose-limiting safety or tolerability signals observed. One final cohort of
peanut allergic patients remains, with dosing expected to extend beyond the
candidate's anticipated therapeutic range. This final stage of the trial is
progressing as planned, with safety and tolerability data to date continuing
to support the candidate's positive profile.

 

A total of 48 subjects have been enrolled and investigated during the trial.

 

Earlier interim analysis
(https://allergytherapeutics2024eutfm.q4web.com/news/news-details/2024/Positive-Interim-Data-from-PROTECT-Trial/default.aspx)
from the first two cohorts of peanut allergic patients, suggested that VLP
Peanut is driving a reduction in allergic response to the major peanut
allergen (Ara h2):

 

·      A protective dose-dependent inhibition of Ara h2 IgE binding to B
cells was observed after treatment with VLP Peanut compared to placebo. This
inhibitory effect is indicative of how VLP Peanut induces blocking antibodies
that may reduce the pro-allergic response.

·      A trend towards a reduction of both basophil sensitivity and
basophil reactivity to Ara h2 was seen, especially for the higher VLP Peanut
dose, and an induction of protective specific IgG towards the major peanut
allergen Ara h2 was observed compared to placebo.

 

Findings from the PROTECT trial will guide dose selection for the Group's
planned Phase IIb trial which is expected to commence in H2 2026.

 

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented:
"These results signal a major advance in the allergy research community's
search for what remains our holy grail - an effective short-course vaccine for
people living with peanut allergy. This vaccine candidate's positive safety
profile, together with encouraging early efficacy signals showing a strong
immune response and reduced allergic reactivity, further strengthen our
confidence in the programme and its potential to transform the lives of those
affected by this most common and severe food allergy. We look forward to
progressing VLP Peanut, the most advanced peanut vaccine programme in the
industry, into Phase IIb development and continuing to lead the way in allergy
innovation."

 

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 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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