Allergy Therapeutics PLC Commencement of dosing in PQ Grass Phase II Trial (0102U)
October 19 2017 - 2:00AM
UK Regulatory
TIDMAGY
RNS Number : 0102U
Allergy Therapeutics PLC
19 October 2017
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
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.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics,
commented: "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."
- ENDS -
For further information, please contact:
Allergy Therapeutics
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Finance Director
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 / Philippa Gardner
allergytherapeutics@consilium-comms.com
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 11,000m(2) 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(R)
). 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(R) . 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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