Allergy Thera. Regulatory News (AGY)

Allergy Therapeutics plc

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

Allergy Therapeutics announces publication of Grass MATA MPL Phase III data in the journal Allergy

17 February 2025 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy immunotherapies, today announces the publication of comprehensive data from its pivotal G306 Phase III trial of Grass MATA MPL, the Group's innovative subcutaneous immunotherapy (SCIT) candidate designed to address the cause of symptoms of allergic rhinoconjunctivitis due grass pollen, in the journal Allergy.

The successful G306 Phase III trial, which completed in November 2023, met its 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. The trial's results supported the recent submission of a Marketing Authorisation Application to the Paul Ehrlich Institut in Germany.

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 just six injections prior to the grass allergy season.

The publication includes new mechanistic insights into Grass MATA MPL's mode of action, supplementing the previously reported positive efficacy and safety data:

· The study reveals how Grass MATA MPL works at a molecular level, showing it triggers multiple protective immune responses through the induction of both IgG4 and IgA (specifically IgA1 and IgA2) antibodies - a more comprehensive immunological effect than seen with other allergy treatments.

· Newly published comparative analysis reveals that no other subcutaneous immunotherapy for respiratory allergies has achieved greater than 14% efficacy improvement in Phase III trials over the past decade - highlighting the significance of Grass MATA MPL's previously reported 20.3% improvement over placebo.

· Patients reported significantly better rhinitis quality of life while using Grass MATA MPL, with a 27.7% improvement compared to placebo - notably higher than achieved with other grass immunotherapy products.

· The publication provides new context showing how Grass MATA MPL's six-injection format, which achieved >95% trial completion, contrasts favourably with traditional immunotherapy treatments requiring up to 100 injections or daily tablets over several years with higher discontinuation rates.

Professor Stefan Zielen, lead author and Principal Investigator from Goethe University, Frankfurt, said: "These comprehensive findings represent an important advance in allergy immunotherapy research. The data demonstrate that Grass MATA MPL stimulates a broader protective immune response than we typically see, activating multiple antibody pathways that help reduce allergic reactions. This deeper understanding of the treatment candidate's mode of action helps explain the strong efficacy we observed in the Phase III trial and, importantly, the significant improvements patients reported in their daily lives."

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "The publication of our G306 data in Allergy, one of the world's leading allergy journals, provides important validation of our innovative approach to allergy immunotherapy. These results reinforce our confidence in Grass MATA MPL's potential to provide an important new treatment option for patients affected by seasonal grass allergy."

- 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

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.

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.