Allergy Therapeutics plc provided an update on the data analysis of its pivotal G306 Phase III trial 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. As previously communicated, the active treatment group demonstrated a highly statistically significant reduction in Combined Symptom & Medication Score (CSMS) (p0.0024) compared to placebo over the peak pollen season. This allowed the Group to stop the study for success and no second season cohort was required.

Further analysis of the dataset shows: Statistical significance was also seen in the eDiary secondary endpoints, including CSMS during the entire grass pollen season, and daily medication and daily symptom scores; A strong, statistically significant induction of the protective biomarker IgG4 was seen during the grass pollen season between active and placebo (p 0.0001); There was a statistically significant overall improvement in the quality-of-life score, according to the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) (p 0.0003); No unexpected safety events were observed with Grass MATA MPL 27,600 SU. The large dataset, including primary and secondary endpoints, is being collated for use in regulatory discussions on the route to market authorisation application. The Group is pleased that the secondary endpoints strongly align, and all data analysed demonstrates the beneficial effect of the Grass MATA MPL 27.,600 SU product.

The first scientific advice meeting with regulators is anticipated to occur in late First Quarter 2024, where discussions will lay out a pathway forward to permit progression to the marketing authorisation application process.