REG - Allergy Therapeutics - Grassmuno® marketing authorisation in Germany

Allergy TherapeuticsAnnouncement

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RNS Number : 6636L  Allergy Therapeutics PLC  16 December 2025

Allergy Therapeutics plc

("Allergy Therapeutics" or the "Company" or the "Group")

 

Allergy Therapeutics granted marketing authorisation for Grassmuno(®) (Grass
MATA MPL) by the German regulatory authority, the Paul Ehrlich Institut

 

-     Regulatory approval in Germany follows submission of comprehensive
evidence package of quality, safety and clinical efficacy supporting
innovative subcutaneous immunotherapy (SCIT) designed to address the cause of
symptoms of allergic rhinoconjunctivitis due to grass pollen

-     First subcutaneous grass-pollen immunotherapy approved under
Germany's TAV programme

-     Commercialisation in Germany anticipated Q1 2026

-     German seasonal allergy market is projected to reach ~US$1 billion
by 2030(1)

-     Company continues its expansion strategy for the product with
potential for regulatory submissions across other major global markets

 

16 December 2025: Allergy Therapeutics plc (AIM: AGY), the integrated
commercial biotechnology company specialising in allergy immunotherapies,
today announces that the Paul Ehrlich Institut (PEI) has granted a marketing
authorisation in Germany for the Group's subcutaneous grass pollen allergen
immunotherapy, Grass MATA MPL, which will be commercialised in the German
market as Grassmuno(®).

 

Grassmuno is a subcutaneous allergen immunotherapy containing a unique mixture
of allergen extracts from grass pollen and the Group's novel adjuvant system,
monophosphoryl lipid-A (MPL(®)) and the biodegradable depot adjuvant
microcrystalline tyrosine (MCT), to increase the immunotherapy's immunogenic
effect. It is indicated for the treatment of moderate to severe allergic
symptoms in adults caused by pollen from grasses (hay fever), such as running
nose (rhinitis), allergic conjunctivitis (rhinoconjunctivitis), without asthma
or with asthma that is well controlled. Treatment is administered before the
grass-pollen season as a six-injection pre-seasonal course.

 

The approval marks the first subcutaneous grass-pollen immunotherapy to be
authorised by the PEI through its TAV (Therapieallergene-Verordnung) framework
and follows the submission of a comprehensive evidence package of quality,
safety and clinical efficacy including the Group's pivotal Phase III G306
trial in adults. In that trial, the immunotherapy demonstrated a highly
statistically significant and clinically relevant reduction in the Combined
Symptom & Medication Score (CSMS) compared to placebo over the peak pollen
season.

 

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "The
regulatory approval of this state-of-the-art short-course aluminium-free
immunotherapy is a defining moment for Allergy Therapeutics and for the future
of allergy immunotherapy in Germany. Grass pollen, a common cause of seasonal
allergy, significantly impacts the lives of many people and new treatment
options are desperately needed. Grassmuno offers an effective, convenient
treatment option for people living with a grass-pollen allergy, and its
authorisation under the TAV regulation validates our clinical excellence and
commitment to quality. It also validates our MATA MPL platform concept and
establishes a strong foundation for our future expansion strategy for this
innovative and disruptive immunotherapy with allergens such as birch and
ragweed across other major global markets."

 

Grass pollen is a key segment within the German seasonal allergy market, which
is projected to reach ~US$1 billion by 2030(1). Grassmuno is expected to be a
major driver of the Group's business in Germany, its largest market, as a
regulatory-approved, short-course treatment approach that can be completed
before the allergy season begins. This offers the potential for people living
with a grass pollen allergy to achieve protection without the burden of
months-long treatment schedules.

 

In November 2024 the Group commenced a Phase III trial
(https://allergytherapeutics2024eutfm.q4web.com/news/news-details/2024/First-Patient-Dosed-in-G308-Paediatric-Trial/default.aspx)
(G308) to evaluate the short- and long-term efficacy and safety of Grass MATA
MPL in a paediatric population. That trial is the first long-term SCIT trial
in a paediatric population and complements Allergy Therapeutics' previous
studies in adults, furthering its comprehensive development strategy for the
immunotherapy across different age groups.

 

Allergy Therapeutics continues to explore the potential for additional
registration opportunities in other major global markets, following engagement
with authorities regarding local regulatory requirements.

 

 

-  ENDS -

 

 

References

1.   Internal company projections

 

 

About Grass MATA MPL

Grass MATA MPL is a subcutaneous allergen immunotherapy to treat moderate to
severe allergic symptoms in adults caused by pollen from grasses, such as
running nose (rhinitis), allergic conjunctivitis (rhinoconjunctivitis),
without asthma or with asthma that is well controlled. It is given before the
start of the pollen season.

 

The immunotherapy 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 (MCT) 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.

 

 

The information contained within this announcement is deemed by the Company
to constitute inside information as stipulated under the Market Abuse
Regulation ("MAR") EU no.596/2014. Upon the publication of this announcement
via Regulatory Information Service ("RIS"), this inside information is now
considered to be in the public domain.

 

 

For further information, please contact:

 

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)

 

 

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/) .

 

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