Allergy Therapeutics PLC Findings from mEEC dose range finding study G204 (2800C)
June 27 2016 - 2:00AM
UK Regulatory
TIDMAGY
RNS Number : 2800C
Allergy Therapeutics PLC
27 June 2016
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(R) 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
allergytherapeutics@consilium-comms.com
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.
This information is provided by RNS
The company news service from the London Stock Exchange
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