Allergy Therapeutics PLC First Patient in Pivotal Phase III Birch Study (6158Z)
March 16 2017 - 2:00AM
UK Regulatory
TIDMAGY
RNS Number : 6158Z
Allergy Therapeutics PLC
16 March 2017
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")
First Patient Recruited in Pivotal Phase III Birch Immunotherapy
B301 Study
16 March 2017 Allergy Therapeutics (AIM:AGY), the fully
integrated specialty pharmaceutical company specialising in allergy
vaccines, today announces the recruitment of the first patient in
its Phase III study designed to evaluate the efficacy and safety of
its ultra-short course, aluminium-free Pollinex(R) Quattro Birch
immunotherapy to address the cause of symptoms of allergic
rhinoconjunctivitis due to birch pollen.
The first patient in the B301 Phase III study was recruited in
Austria on 15 March. The study is anticipated to run for one year
and involve more than 550 patients over 50 sites across Germany,
Sweden, Austria and Poland. The primary objective of this study is
to evaluate the efficacy of Pollinex(R) Quattro Birch in birch
pollen-induced rhinoconjunctivitis and to enable registration of
the product in Germany via the Therapieallergene-Verordnung (TAV)
process of the Paul Ehrlich Institut, before anticipated marketing
authorisation in 2019.
The adopted cumulative dose has been demonstrated to be
efficacious in two recent dose range finding studies with respect
to reduction of symptoms induced by a conjunctival provocation test
(CPT) with no prior safety concerns.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics,
said: "The start of our Phase III trial investigating Pollinex
Quattro Birch marks the beginning of a number of trials aimed at
strengthening our product portfolio across Europe and helping the
6% of Europeans who test positive to birch allergens. If approved,
Pollinex Quattro Birch will be the first MPL adjuvanted ultra-short
course aluminium-free vaccine ever approved. Combined with our
clinical programme in the US focusing on Pollinex Quattro Grass, we
aim to have a comprehensive global modified allergen + MCT(R) and
MPL vaccine package that focuses on delivering convenience, safety,
efficacy and enhanced patient compliance."
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
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.495 employees and is listed on
the London Stock Exchange (AIM:AGY). For more information, please
see www.allergytherapeutics.com.
About Pollinex Quattro Birch
Pollinex Quattro Birch is a unique ultra-short course
allergen-specific immunotherapy comprising three key technologies
tailored to reduce irritation and systemic reactions, namely:
modified allergens, microcrystalline tyrosine (MCT(R) ) and
monophosphoryl lipid A (MPL).
The ultra-short duration of treatment is achieved via allergen
modification that transforms the structure of birch allergens to
allow increased doses to be delivered compared to traditional
unmodified preparations. The potent depot adjuvant, MCT(R) , has a
Th1 immuno-modulating 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.
About Allergic Rhinitis
Allergic rhinitis and conjunctivitis affects between 10% and 30%
of the population worldwide(1) . Symptoms can be intrusive and
debilitating and can include watery eyes, runny nose and
inflammation. Current first line treatments such as antihistamines
and corticosteroids lead to insufficient symptom control and add to
the economic and patient burden. Currently, specific immunotherapy
is the only known treatment that addresses the underlying cause of
symptoms.
References
1. World Health Organization. White Book on Allergy 2011-2012
Executive Summary. By Prof. Ruby Pawankar, MD, PhD, Prof. Giorgio
Walkter Canonica, MD, Prof. Stephen T. Holgate, BSc, MD, DSc, FMed
Sci and Prof. Richard F. Lockey, MD.
This information is provided by RNS
The company news service from the London Stock Exchange
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