RCS - Allergy Therapeutics - Grass MATA MPL Publications in Allergy Journal

Allergy TherapeuticsAnnouncement

31/07/2025 07:01

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250731:nRSe2761Ta&default-theme=true

RNS Number : 2761T  Allergy Therapeutics PLC  31 July 2025

Allergy Therapeutics plc

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

 

Allergy Therapeutics announces publication of three papers in the journal
Allergy that strengthen the evidence base for Grass MATA MPL allergen
immunotherapy

 

·      Key papers published in Allergy summarise the significant and
clinically meaningful effect of Grass MATA MPL throughout the clinical trial
programme

·      Independent patient survey results and clinical trial data were
used to justify the Minimal Clinically Important Difference, further
strengthening the positive outcome of the pivotal G306 Phase 3 trial of Grass
MATA MPL

·      A meta-analysis of two phase III trials was published, showcasing
comparable primary endpoint results and improved overall rhinoconjunctivitis
quality-of-life in Grass MATA MPL compared to grass allergen immunotherapy
products currently registered

·      Grass MATA MPL was shown to be effective and well-tolerated in
the G306 study

 

31 July 2025 Allergy Therapeutics (AIM: AGY), the fully integrated commercial
biotechnology company specialising in allergy immunotherapies, today announces
the publication of three key publications in the journal Allergy supporting
the efficacy, safety and quality-of-life effects of Grass MATA MPL, the
Group's innovative subcutaneous immunotherapy (SCIT) candidate designed
to address the cause of symptoms of allergic rhinoconjunctivitis due to grass
pollen. Allergy is the official journal of EAACI with an impact factor of
12.6, the highest-impact journal in the field of allergy and clinical
immunology.

 

Grass MATA MPL is an aluminium-free, pre-seasonal short-course immunotherapy
designed to address the cause of symptoms of allergic rhinoconjunctivitis due
to grass pollen, using six injections given prior to the grass allergy season.
A Marketing Authorisation Application to the Paul Ehrlich Institut in Germany
is currently under review, following the Group's submission in November 2024.
Should this result in regulatory approval, commercial launch of the product is
anticipated in FY2026.

 

Results from Allergy Therapeutics' G306 Phase III trial, which completed in
November 2023
(https://ir.q4europe.com/solutions/allergytherapeutics2018tf/3856/newsArticle.aspx?storyid=15929578)
, have been published (https://doi.org/10.1111/all.16491) by Zielen et al.,
showing that Grass MATA MPL met the primary endpoint, demonstrating a highly
statistically significant reduction in the Combined Symptom & Medication
Score (CSMS) of 20.3% (p=0.0005) compared to placebo over the peak pollen
season.

 

Furthermore, a meta-analysis of the two Phase III trials in the Grass MATA MPL
programme (G306 and G309) has also been published
(https://doi.org/10.1111/all.16535) by Zielen et al., whereby 674 adult
subjects with allergic rhinitis and/or rhino-conjunctivitis were included. The
results of this meta-analysis showed a similar statistically significant
improvement of 22.5% (p=0.00004) compared to placebo on the primary endpoint
CSMS over the peak grass pollen season.

 

Most recently, Pfaar et al., have published
(https://doi.org/10.1111/all.16654) a paper justifying that primary CSMS
outcome improvements exceeding 16% are clinically relevant, confirming that
Grass MATA MPL achieved levels of clinical relevance both in the G306 trial
and the meta-analysis. In this publication, the minimal clinically important
difference (MCID) for allergy immunotherapy trials was assessed using direct
patient feedback and an anchor-based method using a data driven approach. The
MCID is a level that represents the smallest change in CSMS that is perceived
to be clinically important and meaningful or noticeable for a patient.

 

In a survey of 1071 grass allergic patients, the majority of participants
(69%) considered a 1-point improvement (e.g., from "moderate" to "mild", or
"severe" to "moderate") in their single most severe allergy symptom as
clinically relevant. Furthermore, based on an anchor-based approach using the
rhinitis quality-of-life questionnaire, an MCID of 16% and 0.22 points were
justified as relative and absolute CSMS differences, respectively.

 

Taken together, these three papers complete the publication cycle for the
adult-phase of the clinical programme evaluating Grass MATA MPL. The Group's
G308 long-term paediatric study evaluating Grass MATA MPL in a paediatric
population is ongoing, and the first cohort of grass allergic patients has
completed their first grass pollen season.

 

Professor Stefan Zielen a.D., lead author from Goethe University Frankfurt and
Institute of Respiratory Research, Medaimun GmbH Frankfurt am Main, Germany,
said: "In Germany there is a significant unmet need for allergen immunotherapy
products that directly address the cause of  allergic rhinoconjunctivitis due
to grass pollen, and the excellent data seen throughout the Grass MATA MPL
clinical trial programme support the use of a short-course subcutaneous
immunotherapy to potentially fill this gap."

 

Professor Oliver Pfaar, lead author from the University Hospital,
Philipps-Universität Marburg, Germany said: "As Chair of the EAACI task
force, 'Minimal Clinically Important Difference (MCID) of clinical endpoints
in AIT', I would judge this new evidence-based publication to be an impactful
step in establishing a truly patient-centric research approach. Taken with the
strong data across the Grass MATA MPL trials, these analyses are of utmost
importance for patients suffering from the symptoms of grass allergy."

 

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented:
"This marks the completion of the final stage of publication in our adult
clinical evaluation programme for Grass MATA MPL. Building on the successful
results achieved in the pivotal G306 study, these papers further validate our
short course immunotherapy's potential to provide a vital treatment option for
patients for whom seasonal grass allergy causes meaningful disruptions to
daily life."

 

 

- 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 Grass MATA MPL

Grass MATA MPL is being developed as a pre-seasonal subcutaneous immunotherapy
product for the treatment of allergic rhinitis and/or rhinoconjunctivitis.

 

Grass MATA MPL contains an extract of 13 grass pollens modified with
glutaraldehyde to form allergoids that reduces the reactivity with
immunoglobulin E (IgE) antibodies without a reduction in other important
immunological properties, such as T-cell reactivity. The allergoid is adsorbed
to microcrystalline tyrosine as a depot adjuvant system formulation.
Monophosphoryl lipid-A (MPL), is included as an adjuvant to increase the
immunogenic effect of the immunotherapy and to enhance the switch from an
allergen specific helper T-cell Type 2 (Th2) to helper T-cell Type 1 (Th1)
like immune response.

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRABLGDRRUXDGUG