Allergy Therapeutics PLC House Dust Mite Allergy Vaccine Gains CTA Approval (7777W)
February 14 2017 - 2:00AM
UK Regulatory
TIDMAGY
RNS Number : 7777W
Allergy Therapeutics PLC
14 February 2017
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")
Novel House Dust Mite Allergy Vaccine Gains Clinical Trial
Application Approval
CTA approval in Spain for Phase I AM101 clinical study
evaluating safety of adjuvanted, modified house dust mite allergy
vaccine
14 February 2017 Allergy Therapeutics (AIM:AGY), the fully
integrated specialty pharmaceutical company specialising in allergy
vaccines, today announces that the Phase I clinical study
investigating the safety and tolerability of Acarovac MPL
(monophosphoryl lipid A) has received Clinical Trial Application
(CTA) approval in Spain.
House dust mites are a major cause of perennial allergic
rhinitis and allergic asthma(1) . Acarovac MPL builds on the strong
foundation of technologies employed in the successful Pollinex(R)
Quattro range of subcutaneous allergy immunotherapies, and builds
on the demonstrated efficacy(2) of the existing successful product
platform of Acarovac Plus(TM) , the fastest growing "named-patient
product" in Allergy Therapeutics' Spanish subsidiary. Acarovac MPL
is the only house-dust mite immunotherapy in development utilising
MCT(R) (microcrystalline tyrosine), a natural, biodegradable depot,
and the adjuvant MPL for the treatment of perennial allergic
rhinitis making this vaccine unique in a $1.5 billion per annum
market(3) .
CTA approval has been granted and the Company now expects this
formulation to begin Phase I studies immediately, to assess the
safety and tolerability of two different dose regimens. Both
treatment regimens include a two-to-four week initial up-dosing
phase but differ in the duration of the later maintenance phase.
The Phase I trial of 32 patients is expected to last one year, and
to be delivered on-time in-line with the Company's stated strategic
plan when funding the programme in November 2015. If the Phase I
trial is successful, the Company expects to launch Acarovac MPL in
Spain on a named-patient basis.
Commenting on the CTA approval, Manuel Llobet, Chief Executive
Officer of Allergy Therapeutics, said: "By using the successful
biodegradable adjuvant system of MCT(R) and MPL, integral in our
seasonal marketed vaccines, in a perennial house dust mite vaccine,
we aim to improve both safety and efficacy for the thousands of
patients who suffer year-round due to house dust mite allergy.
Acarovac Quattro will provide convenience to our patients and
doctors and more efficient pharmacoeconomics. Effectively, the
dosing regime in Acarovac Quattro has the potential to improve the
convenience, adherence and compliance that is essential for a
successful treatment, and builds on the acceptance of the existing
Acarovac Plus platform."
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.
References
1. Calderón M et al., Respiratory allergy caused by house dust
mites: What do we really know? J Allergy Clin Immunol. 2015
Jul;136(1):38-48
2. Roger, A., Depreux, N., Jurgens Y., Heath M, Garcia G.,
Skinner M, A novel and well tolerated mite allergoid subcutaneous
immunotherapy: Evidence of clinical and immunologic efficacy.
Immunity, Inflammation and Disease, 2014; 2 (2); 92-98
3. QYR Pharma report. September 2016
This information is provided by RNS
The company news service from the London Stock Exchange
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