TIDMAGY
RNS Number : 5522W
Allergy Therapeutics PLC
13 December 2023
Allergy Therapeutics plc
("Allergy Therapeutics", "ATL" or the "Group")
Positive primary and secondary endpoints of G306 pivotal Phase
III trial investigating
Grass MATA MPL are highly consistent
- Highly significant secondary efficacy endpoints with an
acceptable safety and tolerability profile observed for Grass MATA
MPL
- Scientific advice meetings with relevant health authorities
anticipated in Q1 2024 to discuss plans for progression to a
marketing authorisation application
13 December 2023 Allergy Therapeutics plc (AIM: AGY), the
integrated commercial biotechnology company specialising in allergy
vaccines, today provides an update on the data analysis of 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.
As previously communicated, the active treatment group
demonstrated a highly statistically significant reduction in
Combined Symptom & Medication Score (CSMS) (p<=0.0024)
compared to placebo over the peak pollen season. This allowed the
Group to stop the study for success and no second season cohort was
required.
Further analysis of the dataset shows:
-- Statistical significance was also seen in the eDiary
secondary endpoints, including CSMS during the entire grass pollen
season, and daily medication and daily symptom scores
-- A strong, statistically significant induction of the
protective biomarker IgG4 was seen during the grass pollen season
between active and placebo (p <=0.0001)
-- There was a statistically significant overall improvement in
the quality-of-life score, according to the Rhinoconjunctivitis
Quality of Life Questionnaire (RQLQ) (p <=0.0003)
-- No unexpected safety events were observed with Grass MATA MPL 27,600 SU
The large dataset, including primary and secondary endpoints, is
being collated for use in regulatory discussions on the route to
market authorisation application. The Group is pleased that the
secondary endpoints strongly align, and all data analysed
demonstrates the beneficial effect of the Grass MATA MPL 27,600 SU
product.
The first scientific advice meeting with regulators is
anticipated to occur in late Q1 2024, where discussions will lay
out a pathway forward to permit progression to the marketing
authorisation application process.
Manuel Llobet, CEO at Allergy Therapeutics , stated: "We are
very pleased that the primary and secondary endpoints from this
trial strongly align, and all data analysed demonstrate the
beneficial effect of our Grass MATA MPL product. These data,
alongside the results from our earlier G309 field study, provide a
strong, significant and consistent data package for our discussions
with relevant health authorities."
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
.
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