Allergy Therapeutics plc (AIM: AGY), a UK-based biotechnology company specialising in allergy immunotherapy, announced on Monday that it has submitted a Marketing Authorisation Application (MAA) for its Grass MATA MPL product to the Paul Ehrlich Institut (PEI) in Germany.
This submission, made under the national registration procedure, is based on a comprehensive data package, including results from the pivotal Phase III G306 clinical trial.
Grass MATA MPL, a subcutaneous immunotherapy for allergic rhinoconjunctivitis caused by grass pollen, has shown significant efficacy in clinical trials. In the Phase III G306 trial, it demonstrated a statistically significant reduction in the Combined Symptom & Medication Score (CSMS) compared to placebo during the peak pollen season. The therapy aims to modify the allergic response with just six injections prior to the grass allergy season.
Following standard validation checks by PEI, Allergy Therapeutics expects the formal review process for the MAA to begin soon. Grass MATA MPL incorporates MicroCrystalline Tyrosine (MCT) and Monophosphoryl-lipid A (MPL) to enhance immunogenicity and promote a shift in immune response from Th2 to Th1.
Allergy Therapeutics is focused on developing aluminium-free immunotherapies and offers a range of proprietary and third-party products across Europe and other international markets.
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