TIDMAGY
RNS Number : 6504O
Allergy Therapeutics PLC
21 May 2018
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
Allergy Therapeutics announces positive top-line results from
its Grass MATA MPL
Phase II dose ranging study
- Primary endpoint met with highly statistically significant
dose-response relationship established -
- Optimal Phase III dose identified -
- Phase III study due to commence in 2019 -
21 May 2018 Allergy Therapeutics plc (AIM: AGY), the fully
integrated commercial biotechnology company specialising in allergy
vaccines, today announces highly positive top-line results from its
Grass Modified Allergen Tyrosine Absorbed (MATA) MPL Phase II dose
ranging study (G205). The trial met its primary endpoint of
establishing a dose-response relationship and a Phase III dose.
Approximately 30% of the population in Europe and 25% of the
population of the US are allergic to grass pollen(1) , one of the
most prevalent global aeroallergens.
The key results announced today:
-- Primary endpoint of the trial met with highly statistically
significant dose-response relationship (p<0.0001)
-- All dosing regimens were safe and well tolerated
-- The currently marketed product showed a significant
improvement compared to placebo (p<0.01)
-- Significant increase in immunoglobulin results, highly
consistent with the dose response observed for the primary
endpoint
-- Adherence to the short treatment course was excellent. More
than 95% of patients received the target cumulative dose during six
weekly subcutaneous injections
The G205 trial is a multi-centre, double-blind, placebo
controlled study designed to explore the safety and response of
different cumulative doses of Grass MATA and MPL for grass-pollen
induced seasonal allergic rhinitis. The European study took place
in Germany, Poland and Austria and 447 patients were randomised
into four active arms plus a placebo, evaluating the change in
allergic symptoms as determined by the total symptom score (TSS)
following conjunctival provocation test (CPT) with the objective to
achieve a dose recommended for Phase III development.
Manuel Llobet, CEO at Allergy Therapeutics, stated: "We are
thrilled with these extremely positive results demonstrating dose
dependent efficacy of the product including the current marketed
dose. This study represents a major milestone in our path forward
to a registered grass allergy product in Europe. Additionally, this
brings us closer towards marketing authorisation in the estimated
$2bn US allergy market, a significant opportunity where our product
has the potential to be the first registered subcutaneous
immunotherapy for the treatment of grass allergy. With an optimal
dose identified, we look forward to sharing this new, exciting data
with the health authorities and plan to commence a Phase III study
in 2019.
"Allergy Therapeutics provides the only ultra-short course,
aluminium-free treatment containing our MPL adjuvant in the
European market, and its convenience for patients is driving market
penetration in all our markets."
This announcement contains inside information for the purposes
of Article 7 of Regulatory (EU) No596/2014.
- ENDS -
For further information, please contact:
Allergy Therapeutics
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Chief Financial Officer
Panmure Gordon
+44 (0) 20 7886 2500
Freddy Crossley, Emma Earl, Corporate Finance
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / Ivar Milligan / Philippa Gardner
allergytherapeutics@consilium-comms.com
Stern Investor Relations, Inc.
+1 212 362 1200
Christina Tartaglia
christina@sternir.com
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an international commercial
biotechnology company 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 Grass MATA MPL
Grass MATA MPL 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 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.
If approved, the product will be the first registered
subcutaneous immunotherapy product in the US for grass allergy.
About US allergy market
The US allergy immunotherapy market, which is anticipated to be
the main market for this product, is estimated by the Group to be
worth $2 billion with potential peak grass vaccine sales of
$300-400 million per annum.
1- European Academy of Allergy and Clinical Immunology (EAACI) Global Atlas of Allergy. 2014.
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END
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