Allergy Therapeutics PLC has released further details from the positive top line results of its pivotal Phase III field study G306, evaluating the efficacy and safety of Grass MATA MPL, a short-course subcutaneous allergen-specific immunotherapy (SCIT) candidate for allergic rhinoconjunctivitis due to grass pollen. The trial successfully met its primary endpoint, demonstrating a statistically significant reduction in Combined Symptom Medication Score (CSMS) and a substantial improvement in daily symptoms and use of relief medication among participants receiving Grass MATA MPL.

The trial, which included 555 subjects with allergic conjunctivitis and/or rhinitis, showed a highly statistically significant improvement in the rhinoconjunctivitis quality of life questionnaire (RQLQ) during the peak season. Additionally, the protective biomarker immunoglobulin (IgG4) exhibited a large increase after treatment with Grass MATA MPL, consistent with data from an earlier exploratory field trial.

The treatment was well tolerated with no unexpected safety signals, and the Group is preparing a marketing authorisation application (MAA) for planned submission in Q4 2024. The 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.

Manuel Llobet, CEO at Allergy Therapeutics, expressed the significance of the findings, stating, "The results of our G306 study, alongside the results of our earlier G309 exploratory field study, provide a strong and consistent data package for progression to an MAA submission." He also acknowledged the exceptional work and dedication of the team at Allergy Therapeutics and the partners at multiple trial sites and countries, as well as the participation of the patients in the trial program.

Allergy Therapeutics is an international commercial biotechnology company focused on the treatment and diagnosis of allergic disorders, with a broad pipeline of products in clinical development.