TIDMAGY
RNS Number : 0234Q
Allergy Therapeutics PLC
25 October 2021
Allergy Therapeutics plc
("Allergy Therapeutics", "ATL" or the "Group")
Allergy Therapeutics announces positive top line results from
G309 exploratory field trial to evaluate efficacy and safety of
Grass MATA MPL
- Primary endpoint Combined Symptom Medication Score (CSMS)
achieved with clinically relevant improvement across both active
treatment groups compared to placebo
- Statistically significant reduction in CSMS seen in both
active treatment groups of 29.1% and 36.8% compared to placebo
- Analysis of secondary endpoints including quality of life and
biomarkers, consistent with primary endpoint results
- G306 Phase III pivotal trial on track for commencement in H2 2022 in US and Europe
25 October 2021 Allergy Therapeutics plc (AIM: AGY), the fully
integrated commercial biotechnology company specialising in allergy
vaccines, today announces positive top line results from its
exploratory field study (G309) to evaluate the efficacy and safety
of Grass MATA MPL, the Group's short-course subcutaneous
allergen-specific immunotherapy (SCIT) candidate that aims to
address the cause of symptoms of allergic rhinoconjunctivitis due
to grass pollen. Two short courses of six injections with treatment
durations of six and 14 weeks were tested.
Key results announced today:
-- The primary endpoint of the trial, "CSMS averaged over the
peak pollen season", demonstrated a statistically significant
difference between active and placebo in both active treatment
groups of 29.1% (p=0.0367) and 36.8% (p=0.0088) for the 6 and 14
weeks respectively, indicating a significant reduction in daily
symptoms and use of relief medication among participants receiving
Grass MATA MPL
-- Both dosing regimens were safe and well tolerated
-- Changes in allergen specific IgE and allergen specific IgG4
were consistent with the immunological changes expected following
allergen specific immunotherapy
-- Improvement in rhinoconjunctivitis quality of life
questionnaire (RQLQ) was observed in both active treatment
groups
-- Improvements in the clinical benefits seen in both US and
European populations were comparable
The G309 trial was a double-blind, placebo controlled,
randomised study over one year and involved 119 patients over 14
sites across Germany and the US. Results from the trial will be
used to optimise the study design of the upcoming pivotal Phase III
study (G306), due to begin in H2 2022 in the EU and US.
Further analyses of the G309 trial are now underway by the Group
and full results, including all secondary and other exploratory
endpoints, will be submitted for peer-reviewed publication and
presentation at upcoming key conferences.
Manuel Llobet, CEO at Allergy Therapeutics , stated: "We are
delighted to announce these results demonstrating a clear treatment
effect from our novel, short-course immunotherapy targeting grass
pollen allergies. Grass pollen is one of the most common causes of
seasonal allergic rhinitis in the Western world. Debilitating
symptoms can affect so many aspects of life and new treatment
options are needed.
"The Group used a groundbreaking study design that brought
state-of-the-art learnings in allergy field trial methodology to
examine multiple endpoints and will enable the potential for
extensive biomarker analysis. Significantly, the results will
enable us to optimally design the upcoming pivotal G306 Phase III
field trial, maximising the chances of success and supporting our
regulatory plans for entry into the US. I am grateful for the hard
work and effort put into this trial by our team at Allergy
Therapeutics and everyone across the multiple trial sites, who kept
the trial on course despite the challenges faced by the continuing
COVID-19 pandemic. I would also like to thank the trial
participants, who are vital to our research developing novel,
innovative allergy immunotherapies with the potential to transform
patients' lives."
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
Rupert Dearden, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / David Daley / Davide Salvi
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 aluminium free 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 includes 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 over 9% compound annual
growth since formation, employs c.600 employees and is listed on
the London Stock Exchange (AIM:AGY). For more information, please
see www.allergytherapeutics.com .
About Allergic Rhinitis
Allergic rhinitis and/or rhinoconjunctivitis is a type I
allergic disease to common aeroallergens such as pollen, mould
spores and house dust mite residue. Seasonal allergic rhinitis is
most commonly caused by allergy to pollen from tree, grasses or
weeds, while perennial allergic rhinitis is most commonly
associated with allergy to dust mite residue, mould spores or
animal dander(1)
About Grass MATA MPL
Grass MATA MPL is being developed as a pre-seasonal subcutaneous
immunotherapy product for the treatment of allergic rhinitis and/or
rhinoconjunctivitis.
Grass MATA MPL contains an extract of 13 grass pollens modified
with glutaraldehyde (allergoid) to reduce the reactivity with
immunoglobulin E (IgE) antibodies without a reduction in other
important immunological properties, such as T-cell reactivity. The
allergoid is adsorbed to L-tyrosine as a depot adjuvant system
formulation. Monophosphoryl lipid-A (MPL), is included as an
adjuvant to increase the immunogenic effect of the immunotherapy
and to enhance the switch from an allergen specific helper T-cell
Type 2 (Th2) to helper T-cell Type 1 (Th1) like immune
response.
References
1. van Cauwenberge P, Bachert C, Passalacqua G, Bousquet J,
Canonica GW, Durham SR, et al. Consensus statement on the treatment
of allergic rhinitis. European Academy of Allergology and Clinical
Immunology. Allergy. 2000; 55(2):116-34.
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