Allergy Therapeutics PLC Approval for PQ Grass Phase II trial (9660Q)
September 18 2017 - 2:01AM
UK Regulatory
TIDMAGY
RNS Number : 9660Q
Allergy Therapeutics PLC
18 September 2017
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
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.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics,
commented: "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."
- 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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