Allergy Therapeutics announces positive top line results from G309 exploratory field trial to evaluate efficacy and safety of Grass MATA MPL
October 25 2021 - 6:00AM
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 820Manuel Llobet, Chief Executive OfficerNick Wykeman,
Chief Financial Officer
Panmure Gordon+44 (0) 20 7886
2500Freddy Crossley, Emma Earl, Corporate FinanceRupert Dearden,
Corporate Broking
Consilium Strategic
Communications+44 20 3709 5700Mary-Jane Elliott / David
Daley / Davide Salvi allergytherapeutics@consilium-comms.com
Stern Investor Relations,
Inc.+1 212 362 1200Christina
Tartagliachristina@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 11,000m2 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 dander1
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
- 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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