Allergy Therapeutics, a pharmaceutical group specialising in allergy vaccines, has announced that the fully-funded Phase II clinical trial investigating the dosing of PQ Grass has received clinical trial application (CTA) approval.
PQ Grass is a unique, ultra-short course, aluminium free subcutaneously injected product with the potential to cure grass pollen-induced allergic rhinitis, the Group said.
Also, the US market, which is anticipated to be the main market for this product if successful, is estimated by the Group to be worth $2bn with potential peak sales of $300m per annum. If approved, the product will be the first registered subcutaneous immunotherapy product in the USA.
The Group said that it expects the Phase II trial to begin imminently. The trial will take place in Europe in Germany, Poland and Austria and will involve approximately 440 patients. The results of the trial are expected in H2 2018. The trial is part of a continuing clinical trial programme aimed at developing the PQ Grass platform worldwide. Following completion of this trial, meetings with the regulatory authorities in the US and Germany will be necessary before it progresses to a Phase III trial.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: “This revised Phase II trial will prepare the ground for entry in to the high value US market in which PQ Grass has the potential to become a convenient, best in class, ultra-short course subcutaneous immunotherapy. We look forward to reporting headline data next year as we advance this product.”