27 June 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")
Allergy Therapeutics announces findings from mEEC dose range finding study G204
~ Further dose range finding required and US plans progress with goal of being first to market ~
~ Group's European sales accelerate at 19% growth rate ~
Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces findings from its exploratory Phase II dose-ranging study (G204) for the US GrassMATAMPL clinical development program and informs that the results did not determine a recommended dose for the Phase III trial. A further dose range finding study will be implemented prior to proceeding into the planned pivotal Phase III study. GrassMATAMPL is an ultra-short course subcutaneous allergen specific immunotherapy ("SCIT") administered prior to the grass pollen season.
Based on the successful dose response data identified in the Phase II G203 study for the same US GrassMATAMPL programme, the G204 trial was designed to explore higher dose regimens using the novel technology of the mEEC (mobile environmental exposure chamber) and optimise the recommended dose before starting the pivotal Phase III trial (G306) to be performed in the US.
In contrast to the G203 study, the dose range finding data with the mEEC did not allow the Company to recommend an optimised dose regime to take into Phase III studies for the US. Consequently, Allergy Therapeutics will undertake a further dose-ranging study employing the same successful European dose-finding trial design with a fixed Conjunctival Provocation Test (CPT) which provided robust results for the optimisation of the Company's marketed subcutaneous birch pollen product, Pollinex® Quattro Birch (PQBirch).
The next dose range finding study is planned to start in 2017. Allergy Therapeutics will await the outcome of an End of Phase II meeting with the FDA, scheduled later in 2016, before progressing into Phase III.
Commenting on the announcement, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "Defining the optimal dose is part of late-stage product development and we will revisit dose evaluation as we recently successfully did with our PQ Birch product, using two separate and complimentary dose-ranging studies. Additionally, the new findings of our Phase II EEC study will need to be discussed with FDA before deciding on the recommended dose for the following Phase III registration trial. While still being determined to become the first company to introduce SCIT to the US, a deferred entry time into the market is now anticipated.
"In Europe, our market penetration continues to accelerate, outperforming the market with 19% year-to-date revenue growth*, an increase from the 12% revenue growth* we had achieved in December 2015.
"Elsewhere in the pipeline, we successfully completed a Phase IIb dose finding study for Pollinex Quattro Birch in Germany and Austria earlier this year; we've completed the exploratory dose finding study in the US; set up the protocols for the Acarovac Quattro programme in Spain; and we have initiated the proof-of-concept plan for the VLP Peanut allergy vaccine in Switzerland.
"We are progressing with our plans and are very excited by the prospects of building a leading subcutaneous company in Europe as well as in international markets."
*revenue growth is at constant currency and is supported by the Immunal acquisition.
ENDS
For further information, please contact:
Allergy Therapeutics
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Panmure Gordon
+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 / Matthew Neal / Laura Thornton
[email protected]
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an international specialty pharmaceutical company focussed on the treatment and diagnosis of allergic disorders including immunotherapy vaccines that cure disease. The Company sells proprietary products and third party products from its subsidiaries in nine major European countries and via distribution agreements in an additional ten countries.
Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is headquartered in Worthing, UK with MHRA-approved manufacturing facilities. The Company employs c.420 employees and is listed on the London Stock Exchange (AIM:AGY).
For more information please see www.allergytherapeutics.com.
