Allergy Therapeutics has successfully conducted meetings with the Paul Ehrlich Institut (PEI) to discuss the Chemistry, Manufacture and Controls (CMC) and clinical packages in support of the upcoming Grass MATA MPL Marketing Authorisation Application (MAA), which is on track for submission in Q4 2024. The company has had positive regulatory discussions with the PEI regarding the results of the pivotal G306 Phase III trial and the data in support of CMC requirements for Grass MATA MPL. The PEI confirmed that, subject to regulatory approval procedures and detailed data analysis, the Group may proceed with an MAA.

The completion of the G309 and G306 field studies represents a significant milestone in the company's plans for registration in the US. Both studies included US subjects, supporting a pathway forward to Biologics License Application (BLA) in the US. The company is also planning to include US subjects in the upcoming pediatric study G308. Allergy Therapeutics is preparing the data package for national MAA in Q4 and exploring potential collaborations for US expansion.

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, expressed appreciation for the supportive discussions with the PEI and the progress made in the regulatory submission of Grass MATA MPL. He highlighted the significance of bringing this state-of-the-art vaccine to the market, potentially transforming the lives of millions of patients worldwide.

Grass MATA MPL is being developed as a pre-seasonal subcutaneous immunotherapy product for the treatment of allergic rhinitis and/or rhinoconjunctivitis. It contains an extract of 13 grass pollens modified with glutaraldehyde (allergoid) and Monophosphoryl lipid-A (MPL) as an adjuvant to increase the immunogenic effect of the immunotherapy and enhance the immune response.

Allergy Therapeutics is an international commercial biotechnology company focused on the treatment and diagnosis of allergic disorders, including aluminium-free immunotherapy vaccines. The Group sells proprietary and third-party products in major European countries and via distribution agreements in additional countries. For more information, please see www.allergytherapeutics.com.