TIDMAGY
RNS Number : 5802X
Allergy Therapeutics PLC
09 May 2016
9 May 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")
Allergy Therapeutics announces positive top-line results from
the PQBirch204 Phase II study for birch-induced seasonal allergic
rhinitis
-- Primary endpoint met
-- Statistically significant dose-response relationship (p<0.01)
-- All dosing regimens were safe and well tolerated
-- Adherence was greater than 90%
Allergy Therapeutics, (AIM:AGY), the fully integrated specialty
pharmaceutical company specialising in allergy vaccines, today
announces positive top-line results from the Company's PQBirch204
Phase II study, a multi-centre, double-blind, placebo-controlled
study designed to explore the safety and response of different
cumulative doses of Birch Modified Allergen Tyrosine adsorbed and
MPL(R) (POLLINEX(R) Quattro Birch) for birch pollen induced
seasonal allergic rhinitis.
The study randomised 371 patients into six cumulative dosing
regimens plus a placebo, evaluating the change in Total Symptom
Score (TSS) following a conjunctival provocation test (CPT) with
the objective to achieve a dose recommended for Phase III
development.
Results summary of the PQBirch 204 Phase II study programme
-- The primary endpoint, to demonstrate a statistically
significant (p<0.01) dose-response for the 5000 standardised
units (SU) to 27300 SU, was met. This enables prediction of the
dose to enter Phase III development
-- The study demonstrated a statistically significant
(p<0.01) dose-response for the 5000 standardised units (SU) to
27300SU dose range studied
-- The dose-response closely followed and extended the findings
of the previous dose-response study (PQBirch203), which studied
doses from 600SU to 13600SU
-- PQBirch continues to be well-tolerated and no safety concerns
were reported in any treatment arm. There was no significant
relationship between any adverse drug reaction exhibited and the
respective dosage of allergoid
-- Overall adherence to the dosing regimens was approximately
94% with no relevant differences between treatment arms.
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics,
said: "The results of the PQBirch204 trial are very encouraging and
they reaffirm the potential of our Pollinex platform to treat the
underlying cause of allergic rhinitis. Approximately 6% of the
population in Europe alone is allergic to birch pollen and there
continues to be a need for a safe and well tolerated effective
treatment for this significant health issue. Pollinex is the only
ultra-short course aluminium-free treatment in the market and its
convenience for patients is driving our market penetration in all
our European markets.
"This study is a significant milestone in our route to Marketing
Authorisation and keeps us on track to commence the Phase III study
in early 2017."
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 / Peter Steel / 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
Note 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.
About Birch Modified Allergen Tyrosine adsorbed + MPL
Birch Modified Allergen Tyrosine adsorbed + MPL 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 Birch Modified Allergen Tyrosine
adsorbed + MPL 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 immunomodulating 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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