Allergy Therapeutics plc provided further detail from the positive top line results from its pivotal Phase III field study G306 to evaluate the efficacy and safety of Grass MATA MPL, 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. The trial successfully met its primary endpoint as previously announced on 14 November 2023. An evaluation was conducted in both the EU and US to assess the impact of a treatment regimen consisting of six pre-seasonal injections given over a span of 14 weeks.

The key findings from this evaluation are as follows: The primary endpoint of the trial, Combined Symptom & Medication Score (CSMS) averaged over the peak pollen season, demonstrated a statistically significant improvement of 20.3% (p=0.00024) for Grass MATA MPL compared to placebo, providing evidence of a substantial reduction in daily symptoms and use of relief medication among participants receiving Grass MATA MPL · A highly statistically significant improvement in the rhinoconjunctivitis quality of life questionnaire (RQLQ) (p=0.0003) was observed during the peak season. The protective biomarker immunoglobulin (IgG4), measured during the grass pollen season, showed a large increase of approximately five-fold after treatment with Grass MATA MPL compared to placebo which achieved high statistical significance (p<0.0001) consistent with data from the earlier G309 exploratory field trial. 555 subjects with allergic conjunctivitis and/or rhinitis were randomised and 528 (95%) completed all six injections of Grass MATA MPL or placebo.

Demographics, allergic history and immunoglobulins were generally well-balanced at baseline between the Grass MATA MPL and placebo groups. In total, 278 and 277 patients received Grass MATA MPL and placebo, respectively. As previously communicated, the treatment was well tolerated with no unexpected safety signals.

Further exploratory endpoint analyses (including an extensive biomarker evaluation) of the G306 trial are now underway. Full results, including secondary and exploratory endpoints, will be presented at the upcoming European Academy of Allergy & Clinical Immunology conference in June 2024 and submitted for peer-reviewed publication later this year. The Group's preparation for the marketing authorisation application (MAA) is well underway, with a planned submission in fourth quarter 2024.