Allergy Therapeutics PLC PQ Birch Phase III trial completes recruitment (2889B)
January 09 2018 - 2:00AM
UK Regulatory
TIDMAGY
RNS Number : 2889B
Allergy Therapeutics PLC
09 January 2018
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
PQ Birch Phase III clinical trial completes recruitment
9 January 2018 Allergy Therapeutics plc (AIM:AGY), the fully
integrated specialty pharmaceutical group specialising in allergy
vaccines, today announces that recruitment of the Group's Phase III
clinical trial with PQ Birch (PQBirch301) has been completed as
expected. The PQBirch301 study is a pivotal Phase III study
designed to evaluate the safety and efficacy of the Group's
ultra-short course, convenient for patients, aluminium free PQ
Birch subcutaneous immunotherapy to address the cause of symptoms
of allergic rhinoconjunctivitis due to birch pollen.
The PQBirch301 study has randomised over 560 patients from 59
centres in four European countries: Germany, Austria, Poland and
Sweden. The primary efficacy data will be assessed during the birch
pollen season of 2018 and the results of the trial are expected
during H2 2018. The successful completion of this pivotal Phase III
study would fulfil the requirements for PQ Birch under the
Therapieallergene-Verordnung (TAV) of the Paul Ehrlich Institut
before anticipated marketing authorisation.
PQ Birch is one of a number of ultra-short course, subcutaneous
immunotherapy products in clinical development for various
allergies, and these form a key component of the Group's
three-pillar growth strategy. This includes: developing a strong
pipeline facilitated by investment from the growing, profitable
European revenue stream; expanding the existing European business;
and preparing for product entry into the US market. The PQ family
of products complement the Group's existing European marketed
portfolio of convenient short course subcutaneous immunotherapy
products and are particularly suited to the changing regulatory
environment for allergy products in the US
Approximately 6% of the population of Europe alone is allergic
to birch pollen(1) and there continues to be a need for a safe and
well tolerated effective treatment for this significant health
issue.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics,
commented: "The completion of recruitment in our pivotal Phase III
clinical study with PQ Birch is an important milestone for the
Group. Marketing authorisation of the first MPL-adjuvanted,
ultra-short course aluminium free vaccine available to patients
will strengthen the Group's portfolio and help address the current
unmet needs in allergy."
(1) DataMonitor Epidemiology Report. 2011
- 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, 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 Pollinex Quattro
Pollinex Quattro is a unique allergen-specific immunotherapy
that comprises three key technologies tailored to reduce irritation
and systemic reactions; modified allergens, microcrystalline
tyrosine (MCT) and Monophosphoryl lipid A (MPL).
The ultra-short duration of Pollinex Quattro is achieved via
allergen modification that transforms the structure of allergens to
allow increased doses to be delivered compared to traditional
unmodified preparations. The potent depot adjuvant, MCT, has a Th1
immunomodulation action that acts in synergy with the TLR4 receptor
agonist MPL to augment a shift in the immune reactions responsible
for the symptoms of allergic rhinitis.
This information is provided by RNS
The company news service from the London Stock Exchange
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