Allergy Therapeutics plc (LON:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announced that dosing has commenced in its G205 Phase II study 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.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: “The start of treatment in this important Phase II trial marks an exciting and critical period of trials for the Group’s research and development pipeline. This trial aims to strengthen the Group’s portfolio in Europe and the US and takes us another step closer to treating patients in the major US market.”
The study is anticipated to run for one year and involve approximately 440 patients in more than 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 birch pollen product resulting in selection and approval of dose for use in a current phase III study. The results of the G205 trial are expected in H2 2018. Following completion of this trial, meetings with the regulatory authorities in the US and Germany will be necessary to enable Phase III trial design.
The US allergy immunotherapy market, which is anticipated to be the main market for this product, 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.