19 October 2017
Allergy Therapeutics plc - Commencement of dosing in PQ Grass Phase II Trial
19 October 2017 Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical group specialising in allergy vaccines, today announces 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.
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.
“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.”
Manuel LlobetChief Executive Officer of Allergy Therapeutics
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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.