REG - Allergy Therapeutics - Phase I VLP Peanut PROTECT trial progress

Allergy TherapeuticsAnnouncement

26/09/2023 07:00

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RNS Number : 5954N  Allergy Therapeutics PLC  26 September 2023

 

 

Allergy Therapeutics plc

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

 

 

Allergy Therapeutics reports progress of Phase I VLP Peanut PROTECT Trial

 

-      Approval granted to commence escalating subcutaneous dosing in
peanut allergic patients

-      25-fold dose escalation successfully completed in healthy subjects
using VLP Peanut vaccine candidate

-      Safety review committee approves further dose escalation in
subsequent cohorts

 

26 September 2023 Allergy Therapeutics (AIM: AGY), the fully integrated
commercial biotechnology company specialising in allergy vaccines, today
announces the completion of dosing of healthy volunteers in the first two
cohorts in the Phase I PROTECT trial ("PROTECT trial") of its novel virus-like
particle (VLP)-based peanut allergy vaccine candidate ("VLP Peanut"). Dosing
of the subsequent cohorts will begin now that the approval from the external
safety review committee (SRC) has been received.

 

Additionally, after the successful skin-prick testing phase completed in April
2023
(https://ir.q4europe.com/solutions/allergytherapeutics2018tf/3856/newsArticle.aspx?storyid=15749002)
, the SRC approved the commencement of subcutaneous dose escalation in peanut
allergic subjects, marking the start of the early proof of concept phase of
the PROTECT trial. This pivotal stage of the PROTECT trial is expected to
begin imminently. The full results from the trial are expected in 2024.

 

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "We
welcome the positive progress in our PROTECT trial and are pleased with the
safety review committee's approval to begin multiple subcutaneous dosing of
peanut allergic patients in the final phase of the trial."

 

"Peanut allergy is one of the most common types of food allergies. For some
people, even the smallest amounts of peanuts can cause a potentially
life-threatening reaction. A safe and effective short-course vaccine that
provides long-term protection and a long-lasting protective immune response
can bring a paradigm shift in treating peanut allergy, changing the lives of
those living with the allergy."

 

The PROTECT trial is being conducted in both healthy volunteers and peanut
allergic patients and consists of two parts:

 

·    Part A: Open-label study of four cohorts of healthy subjects (Group
A1) who undergo subcutaneous dosing with ascending concentrations of VLP
Peanut. Peanut allergic subjects (Group A2) underwent skin prick tests
performed with ascending concentrations of the vaccine candidate (completed
April 2023).

 

·    Part B: Double-blind, placebo-controlled Part B enrolling peanut
allergic patients who receive ascending doses of the vaccine candidate
administered subcutaneously.

 

The PROTECT trial builds on the findings from the VLP001 study, which took
place at Imperial College London. This ex-vivo biomarker study revealed that
VLP Peanut significantly reduced certain allergic responses compared to the
major allergen Ara h2, indicating a promising safety profile with reduced
potential to induce allergic reactions.

 

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 Article 7 of
the UK Market Abuse Regulations.

 

 

- ENDS -

 

 

For further information, please contact:

 

Allergy Therapeutics

+44 (0) 1903 845 820

Manuel Llobet, Chief Executive Officer

Shaun Furlong, Chief Financial Officer

 

Panmure Gordon (Nominated Adviser and Broker)

+44 (0) 20 7886 2500

Emma Earl, Mark Rogers, Freddy Crossley, Corporate Finance

Rupert Dearden, Corporate Broking

 

Consilium Strategic Communications

+44 20 3709 5700

Mary-Jane Elliott / David Daley / Davide Salvi

allergytherapeutics@consilium-comms.com
(mailto:allergytherapeutics@consilium-comms.com)

 

Notes for editors:

 

About Allergy Therapeutics

 

Allergy Therapeutics is an international commercial biotechnology company
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. Its broad pipeline of products in clinical development includes
vaccines for grass, tree and house dust mite, and peanut allergy vaccine in
pre-clinical development. Adjuvant systems to boost performance of vaccines
outside allergy are also in development.

 

Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is
headquartered in Worthing, UK with more than 11,000m(2) of state-of-the-art
MHRA-approved manufacturing facilities and laboratories. The Group, which
employs c.600 employees, is listed on the London Stock Exchange (AIM:AGY). For
more information, please see www.allergytherapeutics.com
(http://www.allergytherapeutics.com) .

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