REG - Allergy Therapeutics - G308 Phase III Year 2 Patient Screening Starts

Allergy TherapeuticsAnnouncement

30/10/2025 07:00

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RNS Number : 4066F  Allergy Therapeutics PLC  30 October 2025

Allergy Therapeutics plc

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

 

Grass MATA MPL in paediatric patients - commencement of patient screening

for second year of the G308 Phase III trial evaluating long-term efficacy and
safety

 

-       G308 paediatric study progresses to planned second year of
recruitment and will evaluate short-term efficacy and safety

-       Industry first subcutaneous allergen-specific immunotherapy
trial designed to evaluate both short and long-term efficacy and safety in
paediatric subjects

-       Short-term safety data from the first year expected to be
announced in Q4 2025

 

30 October 2025 Allergy Therapeutics (AIM: AGY), the fully integrated
commercial biotechnology company specialising in allergy immunotherapies,
announces that the first subjects have been screened for inclusion in the
second year of the Phase III G308 trial that aims to evaluate both the short
and long-term efficacy and safety of Grass MATA MPL in paediatric subjects.

 

The screening and randomisation period is planned to be completed by early Q1
2026 to allow all scheduled injections of Grass MATA MPL to be administered
prior to the commencement of the 2026 grass pollen season.

 

The second year of recruitment in the G308 trial aims to achieve a similar
number of randomised participants as the first year, in which 190 participants
were randomised. This will allow a full analysis of the short-term safety and
efficacy results of the G308 study in Q4 2026, with short-term safety data
from the first year expected to be announced in Q4 2025. Patients selected for
the long-term extension will progress to a further three years of active
treatment or placebo. This will be followed by two years of treatment-free
follow-up, after which the long-term primary efficacy & safety will be
evaluated.

 

The G308 study has been designed to ensure that only a minority of patients
will receive long-term treatment of placebo (~8-13% probability), which is an
important improvement from the EMA standard design (50% probability) and will
enable the majority of paediatric patients to receive long-term active
treatment.

 

Manuel Llobet, CEO of Allergy Therapeutics, commented: "The commencement of
screening in the second year of our Phase III G308 trial builds upon our
commitment to addressing the unmet needs of the paediatric population in grass
allergy. Overall we have invested over $100M in clinical development in grass
allergy to date and combined with our successful adult trials, this long-term
trial will help us in our aim to provide children affected by grass allergies
with an alternative treatment journey that is less burdensome compared to
taking tablets daily."

 

 

- 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 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.

 

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