TIDMAGY
RNS Number : 3057T
Allergy Therapeutics PLC
14 November 2023
Allergy Therapeutics plc
("Allergy Therapeutics", "ATL" or the "Group")
G306 pivotal Phase III trial to evaluate efficacy and safety of
Grass MATA MPL meets primary endpoint
- Study demonstrated a highly statistically significant
reduction in Combined Symptom & Medication Score (CSMS)
(p<=0.0024) achieved in active treatment group compared to
placebo
- Analysis of primary outcome and secondary endpoints including
quality of life and biomarkers to be announced once full analysis
of the data has been completed
14 November 2023 Allergy Therapeutics plc (AIM: AGY), the
integrated commercial biotechnology company specialising in allergy
vaccines, today announces interim top line results from its pivotal
G306 Phase III trial 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.
The adaptive G306 study design, endorsed by regulators, allowed
an interim analysis to determine whether a 2nd cohort would be
required. The trial met its primary endpoint demonstrating
statistically significant superiority of Grass MATA MPL compared to
placebo (p <=0.0024, one-sided) in the CSMS during the peak
pollen season, and the study was stopped for success. Top line
analysis is expected to be available in mid-December. This will
include treatment effect data and secondary endpoint analysis.
The G306 trial was a multi-centre, randomised, parallel group,
double-blind, placebo-controlled clinical trial to evaluate the
efficacy of Grass MATA MPL 27600 SU in subjects with grass pollen
induced seasonal allergic rhinitis and/or rhinoconjunctivitis based
on symptoms and medications. The trial was conducted in the US and
Europe at 89 sites.
Manuel Llobet, CEO at Allergy Therapeutics , stated: "The
completion of the G306 study is an important milestone in our
efforts to register this innovative treatment for the benefit of
the millions of patients affected by grass allergies. I would like
to thank our trial investigators, the team at Allergy Therapeutics
and, most importantly, the patients, for their contributions. This
result builds upon the statistical significance also seen in the
earlier G309(1) field study and, subject to full top line analysis,
we look forward to commencing discussions with relevant regulatory
authorities to continue our journey to bring this important product
to market."
Preparation for a clinical trial application for the Group's
G308 paediatric study is currently underway to meet the previously
communicated requirements of the German regulatory framework
(Therapy Allergen Ordinance) as well as the approved Paediatric
Investigation Plan (PIP).
This announcement contains inside information for the purposes
of Article 7 of Regulatory (EU) No596/2014.
- ENDS -
For further information, please contact:
Allergy Therapeutics
Manuel Llobet, Chief Executive Officer
Shaun Furlong , Chief Financial Officer
+44 (0)1903 845 820
Panmure Gordon
Emma Earl, Mark Rogers, Freddy Crossley, Corporate Finance
Rupert Dearden, Corporate Broking
+44 (0) 20 7886 2500
ICR Consilium
Mary-Jane Elliott / David Daley / Davide Salvi
+44 20 3709 5700
allergytherapeutics@consilium-comms.com
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an international commercial
biotechnology company, headquartered in the UK, 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, house dust mite and peanut. 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(2)
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.
More information about the Phase III G306 Grass MATA MPL trial
can be found on ClinicalTrials.gov under the identifier NCT05540717
.
References
1. Short-course subcutaneous treatment with PQ Grass strongly
improves symptom and medication scores in grass allergy. de Kam PJ,
Zielen S, Bernstein JA, Berger U, Berger M, Cuevas M, Cypcar D,
Fuhr-Horst A, Greisner WA, Jandl M, Laßmann S, Worm M, Matz J, Sher
E, Smith C, Steven GC, Mösges R, Shamji MH, DuBuske L, Borghese F,
Oluwayi K, Zwingers T, Seybold M, Armfield O, Heath MD, Hewings SJ,
Kramer MF, Skinner MA. Allergy. 2023 Oct;78(10):2756-2766.
2. 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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