REG - Allergy Therapeutics - Positive Interim Data from PROTECT Trial

Allergy TherapeuticsAnnouncement

04/12/2024 07:00

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RNS Number : 6783O  Allergy Therapeutics PLC  04 December 2024

Allergy Therapeutics plc

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

 

Allergy Therapeutics announces positive interim analysis data from the Phase
I/IIa VLP Peanut PROTECT Trial

 

·      Interim efficacy biomarker analysis of the first two of four
peanut allergic patient cohorts demonstrates a positive and consistent
immunological response to VLP Peanut

·      Dose-dependent reduction in wheal size after skin-prick testing
indicates the skin is becoming significantly less reactive to peanut extract
in patients receiving VLP Peanut compared to placebo

·      Observed biomarker profile, including induction of protective
antibodies and reduced basophil reactivity at relatively low doses, suggests
that VLP Peanut has the potential to simultaneously elicit a strong boost of
the immune system while suppressing an allergic response

 

04 December 2024 Allergy Therapeutics (AIM: AGY), the fully integrated
commercial biotechnology company specialising in allergy immunotherapies,
today announces positive interim biomarker efficacy data from its Phase I/IIa
VLP Peanut PROTECT trial, demonstrating the first evidence of treatment effect
in peanut allergic patients.

 

Interim analysis of the first two cohorts of peanut allergic patients showed
that treatment with VLP Peanut resulted in a meaningful dose-dependent
reduction in skin sensitivity to peanut allergen, with treated patients in
cohort 2 showing a 48% reduction in wheal size after skin-prick test compared
to an 8% reduction in those treated with placebo.

 

Additionally, a comparison of the biomarker profile between treatment and
placebo points to VLP Peanut 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.

 

This interim analysis stage involved 12 peanut allergic patients across three
treatment groups. The data represents the first demonstration of an
immunologic response using a nanoparticle-based approach in peanut allergic
patients. Following administration of initial escalating doses, patients
underwent comprehensive assessment including skin-prick testing with whole
peanut extract and blood sampling to identify key biomarkers of efficacy. As
previously communicated
(https://ir.q4europe.com/solutions/allergytherapeutics2018tf/3856/newsArticle.aspx?storyid=16223829)
, no relevant safety signals have been observed to date.

 

Prof. Mohamed Shamji, Imperial College London, commented: "Peanut allergy
affects around 3% of the worldwide population and there remain gaps in current
therapeutic options. Novel therapeutics are needed and the interim findings
from the PROTECT study demonstrate a desirable clinical immunologic response.
This includes a reduction in skin reactivity and basophil responsiveness in
peanut allergic patients and a dose-dependent induction of IgG antibodies with
inhibitory activity of IgE binding to B-Cells. Taken together, these findings
support the modulation of the peanut induced allergic response and supports
VLP Peanut being potentially effective and safe as a novel therapeutic for
peanut allergy.''

 

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented:
"These initial efficacy results mark an important milestone for our peanut
allergy programme. The consistency in immunological response seen at these
early doses is particularly encouraging. Combined with the positive safety
profile, this data supports our plans to progress to higher doses in the
remaining cohorts as we work towards identifying an optimal therapeutic dose
for phase II development."

 

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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