Allergy Therapeutics has begin its G205 Phase II study to check the dose-response and safety of its ultra-short course, aluminium free PQ Grass immunotherapy. It will be used to treat the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen.
The study should run for one year with about 440 patients in more than 50 sites across Germany, Austria and Poland. Allergy Therapeutics expects the trial 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.
Allergy Therapeutics points out in its press release that 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.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said the 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. He said: “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.”