Commencement of Phase III Paediatric Trial

Allergy Therapeutics plc

("Allergy Therapeutics" or "the Group")

Allergy Therapeutics commences Phase III paediatric trial for Grass MATA MPL

·      Industry first long-term subcutaneous allergen-specific immunotherapy (SCIT) trial for grass pollen in paediatric subjects

·      Patient screening and enrolment underway with topline safety and efficacy data expected Q4 2025

21 October 2024 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces that the first subjects have been screened and enrolled in the Group's Phase III G308 trial to evaluate the long-term efficacy and safety of Grass MATA MPL in paediatric subjects.  

Grass MATA MPL is the Group's short-course subcutaneous allergen-specific immunotherapy (SCIT) candidate that aims to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen.

Incorporating MicroCrystalline Tyrosine ("MCT^®") adsorbed allergoids and the innovative adjuvant Monophosphoryl-lipid A ("MPL"), the immunotherapy candidate has been developed to modify the allergic response following only six injections prior to the grass allergy season.

Commencement of the G308 paediatric trial follows the successful earlier completion of the Group's pivotal Phase III G306 trial in adults. In that trial, Grass MATA MPL demonstrated a highly statistically significant reduction in the Combined Symptom & Medication Score (CSMS) compared to placebo over the peak pollen season. Building on these positive results, G308 is designed to evaluate the long-term efficacy and safety of the immunotherapy candidate in a paediatric population over five years. Topline safety and efficacy data are expected in Q4 2025.

The G308 paediatric trial complements Allergy Therapeutics' previous studies in adults, including the pivotal Phase III G306 trial and the exploratory G309 field study, furthering the Group's comprehensive development strategy for Grass MATA MPL across different age groups.

Manuel Llobet, CEO of Allergy Therapeutics, commented: "The commencement of our long-term paediatric Phase III trial (G308) marks the first time a SCIT grass pollen vaccine has been evaluated in a paediatric population over the long-term, a significant milestone in the allergy industry. Encouraged by the results of our short-course grass pollen immunotherapy in both the successful G309 exploratory field trial and the pivotal G306 trial, we are excited to advance the development of this innovative treatment candidate in new patient populations, potentially offering a transformative option for children with grass pollen allergies."

- ENDS -

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 / Rory Sale

Nigel Birks - Life Science Specialist Sales

Tamar Cranford Smith - Sales

+44 (0)20 7220 0500

ICR Consilium

Mary-Jane Elliott / David Daley / Davide Salvi

+44 (0)20 3709 5700

[email protected]

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 immunotherapy vaccines 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.