Approval of clinical trial application for PQ Grass Phase II trial
- Trial aimed at determining optimal dose of an MPL-adjuvanted, modified grass allergy vaccine -
18 September 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces 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 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 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.
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.”
Manuel LlobetChief Executive Officer of Allergy Therapeutics
- ENDS -
For further information, please contact:
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Finance Director
+44 (0) 20 7886 2500
Freddy Crossley / Duncan Monteith, Corporate Finance
Tom Salvesen, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / Ivar Milligan / Philippa Gardner
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an international specialty pharmaceutical group focussed on the treatment and diagnosis of allergic disorders, including immunotherapy vaccines that have the potential to cure disease. The Group sells proprietary and third party products from its subsidiaries in nine major European countries and via distribution agreements in an additional ten countries. Its broad pipeline of products in clinical development include vaccines for grass, tree and house dust mite, and peanut allergy vaccine in pre-clinical development. Adjuvant systems to boost performance of vaccines outside allergy are also in development.
Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is headquartered in Worthing, UK with more than 11,000m2 of state-of-the-art MHRA-approved manufacturing facilities and laboratories. The Group, which has achieved double digit compound annual growth since formation, employs c.500 employees and is listed on the London Stock Exchange (AIM:AGY). For more information, please see www.allergytherapeutics.com.
About PQ Grass
PQ Grass contains three distinct components: allergoids, micro crystalline tyrosine (MCT) and monophosphoryl lipid A (MPL®). Allergoids (natural allergens chemically modified to form allergoids) exhibit reduced allergenicity that improves safety and allows for delivery of higher doses. These are combined with the depot adjuvant technology MCT to provide enhanced immune exposure and further improved tolerability. Finally, the immune response is specifically enhanced and directed by the adjuvant MPL®. MPL is a toll-like 4 receptor (TLR4) agonist which has been extensively used in the Group’s other allergy vaccines available on the market and in vaccines registered in the USA.