Allergy Therapeutics plc (LON:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announced that recruitment has been completed in its grass allergy Phase II study (G205), with results due ahead of expectations in early H2 2018. The trial is designed to evaluate the dose-response and safety of its ultra-short course, aluminium free PQ Grass immunotherapy to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen.
The study protocol involves more than 440 patients in over 50 sites across Germany, Austria and Poland. The trial is designed to identify the optimal efficacious cumulative dose using conjunctival provocation testing. This type of challenge testing has recently been used in studies for a similar subcutaneous allergoid MPL product resulting in selection and approval of dose for use in a phase III study.
One of the key markets for this global product is expected to be the US. The US allergy immunotherapy market is estimated by the Group to be worth $2 billion with potential peak grass vaccine sales of $300-400 million per annum. If approved, the product will be the first registered subcutaneous immunotherapy product in the US for allergy.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics Plc, commented: “The completion of recruitment for all patients in our Phase II trial is an important step in our journey towards access to the US market in which PQ Grass has the potential to become a convenient, best in class, ultra-short course subcutaneous immunotherapy. We are pleased that the study is running ahead of schedule and look forward to seeing the results later this year.”