Opening the door to registration

AGY is a long-established specialist in the prevention, diagnosis and treatment of allergies. Pollinex Quattro (PQ) Grass, the subcutaneous allergy immunotherapy (SCIT), continues to gain market share despite being available in the EU only on a ‘Named Patient’ basis. As part of a programme designed to get PQ Grass formally approved in both Europe and the US, AGY has announced positive results from its Phase II dose-ranging clinical trial. It has identified the optimum dose as needed to move forward into the final Phase III efficacy trials, and to become the first SCIT product to be registered in these important pharmaceutical markets.

• Strategy: AGY is a fully-integrated pharmaceutical company focused on the treatment of allergies. There are three parts to its strategy: continued development of its European business via investment or opportunistic acquisitions; the US PQ opportunity; and further development of its pipeline.
• G205 trial: As part of an agreed programme with both the TherapieallergeneVerordnung (TAV) and the US Food and Drug Administration (FDA), AGY has undertaken a Phase II dose-ranging study with Modified Allergen Tyrosine Absorbed (MATA) MPL (PQ Grass) to identify the optimal dose for Phase III.
• Results: Headline data provided everything that AGY could have hoped for: a strong dose-response relationship (p<0.001); extremely well tolerated; and an excellent adherence rate (>95%). Results also allowed the company to identify the optimal dose for Phase III trials, subject to regulatory discussions.
• Next steps: This trial was extremely important because it was a required step in the programme towards regulatory approval of PQ Grass in both Europe and the US. Although overall protocols for the Phase III trials in the EU and US might be slightly different, they are likely to use the same dose, and start in 1H 2019.
• Investment summary: Success in the Phase II G205 trial was important for moving PQ Grass to the next stage. The resounding results will make upcoming discussions with the respective regulators somewhat easier, paving the way for commencement of the final Phase III trials which, in turn, open the door to PQ Grass becoming the first registered ultra-short-course allergy immunotherapy product in both Europe and the US.