Allergy Therapeutics plc announced interim top line results from 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. The adaptive G306 study design, endorsed by regulators, allowed an interim analysis to determine whether a 2nd cohort would be required. The trial met its primary endpoint demonstrating statistically significant superiority of Grass MATA MPL compared to placebo (p =0.0024, one-sided) in the CSMS during the peak pollen season, and the study was stopped for success.

Top line analysis is expected to be available in mid-December. This will include treatment effect data and secondary endpoint analysis. The G306 trial was a multi-centre, randomised, parallel group, double-blind, placebo-controlled clinical trial to evaluate the efficacy of Grass MATA MPL 27600 SU in subjects with grass pollen induced seasonal allergic rhinitis and/or rhinoconjunctivitis based on symptoms and medications.

The trial was conducted in the US and Europe at 89 sites. Preparation for a clinical trial application for the Group's G308 paediatric study is currently underway to meet the previously communicated requirements of the German regulatory framework (Therapy Allergen Ordinance) as well as the approved Paediatric Investigation Plan (PIP).