REG - Allergy Therapeutics - Advancement to final phase of PROTECT trial

Allergy TherapeuticsAnnouncement

27/03/2025 07:15

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RNS Number : 3873C  Allergy Therapeutics PLC  27 March 2025

Allergy Therapeutics plc

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

 

Allergy Therapeutics advances to the final phase of treatment in Phase I/IIa
VLP Peanut PROTECT trial and announces publication of mechanism of action data

 

·      Healthy volunteers now receiving highest doses with no safety
signals observed

·      Third cohort of peanut allergic patients progressing through
therapeutic dose range

·      New peer-reviewed publication in Journal of Allergy and Clinical
Immunology validates mechanism of action

 

27 March 2025 Allergy Therapeutics (AIM: AGY), the fully integrated commercial
biotechnology company specialising in allergy immunotherapies, today announces
that its VLP Peanut Phase I/IIa PROTECT trial has entered the final phase of
treatment, with healthy volunteers progressing to the highest dose levels and
no safety signals observed to date.

 

As part of this phase, the final cohort of healthy volunteers is now receiving
subcutaneous doses of VLP Peanut, the Group's innovative, short-course peanut
allergy vaccine candidate, beyond the expected therapeutic dose level to
establish a strong safety margin. Meanwhile, the third of four planned cohorts
of peanut-allergic patients is progressing through dose escalation, also
including levels beyond the anticipated therapeutic range. These data will
supplement previously reported
(https://files.q4europe.com/news-pdf/476395/AllergyTherapeutics2018TF_16298418.pdf)
biomarker efficacy findings observed at lower cumulative doses, strengthening
the understanding of treatment response at higher doses.

 

Results from the current patient cohort will also be key in defining the
optimal dose range for the upcoming Phase IIb study while reinforcing
confidence in the treatment's safety profile. Both healthy volunteers and
peanut-allergic patients have progressed through their initial dose
escalation, and, following a safety review, the committee has recommended
advancing to the second of three planned dose increases for each cohort.

 

In addition, Allergy Therapeutics announces the publication of a new paper
(https://www.jacionline.org/article/S0091-6749(24)00860-1/abstract) in the
Journal of Allergy and Clinical Immunology (JACI), which evaluates the
beneficial tolerogenic properties and immunological reactivity of VLP Peanut.

 

Peanut allergy remains a growing public health concern, particularly in the US
and Europe, with limited effective treatment options. Results detailed in the
paper, from earlier research conducted by Allergy Therapeutics, demonstrate
that VLP Peanut can reduce allergic responses while promoting protective
immune mechanisms in cells from peanut-allergic individuals. Preliminary skin
testing in six peanut-allergic adults further confirmed the vaccine candidate
was safe and well tolerated.

 

The PROTECT trial continues to progress to plan and the Company expects to
announce the initial topline data later this summer.

 

Professor Mohamed Shamji, Professor of Immunology and Allergy at Imperial
College London and senior author of the paper, commented: "There remains an
urgent and compelling need for a therapy that not only ensures sustained
protection during extended treatment-free periods but also holds the promise
of curing peanut allergies. Our dedicated efforts are aimed at fulfilling this
significant unmet need, and the data we have collected thus far are
exceptionally promising. We have established that the vaccine not only
circumvents triggering allergic reactions but also skilfully modulates the
immune system, potentially leading to long-term protection. This marks a
significant advancement in food allergy therapeutics, and the findings from
the clinical trial phase set the stage for new therapies for peanut allergy.''

 

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)
.

 

 

- 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 / Rory Sale

Nigel Birks - Life Science Specialist Sales

Tamar Cranford Smith - 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 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.

 

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