Allergy Therapeutics
plc
("Allergy
Therapeutics" or "the Group")
Allergy Therapeutics
announces successful meetings with Paul Ehrlich Institut to enable
MAA plans for Grass MATA MPL
- Collaborative meetings held
with the Paul Ehrlich Institut (PEI) to discuss proposed Chemistry,
Manufacture and Controls (CMC) and clinical packages in support of
upcoming Grass MATA MPL Marketing Authorisation Application (MAA),
on track for submission in Q4 2024
-
By including patients from the US, the G306 and G309 trials
were designed as supportive to enable a pathway for Biologics
License Application (BLA) in the US
3
June 2024 Allergy Therapeutics (AIM:
AGY), the fully integrated commercial biotechnology company
specialising in allergy vaccines, today announces updates on
progression of the Group's MAA preparation for Grass MATA
MPL.
Developing a comprehensive data package
Positive regulatory discussions have
been held with the PEI regarding the results of the pivotal G306
Phase III trial, as well as the data in support of CMC requirements
and the subsequent regulatory pathway to national registration 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.
During the meetings, key trial data
from the pivotal G306 Phase III trial were shared, alongside
supporting CMC data that the Group plans to use as the basis for
the proposed marketing authorisation application. Feedback was
constructive and PEI confirmed that, subject to the usual
regulatory approval procedures and detailed data analysis, the
Group may proceed with an MAA. As previously announced, the Group
intends to submit an MAA in Q4 2024.
Supportive of US strategy
Completion of the G309 and G306
field studies represents a significant milestone in plans for
registration in the US. Following an earlier successful end of
phase 2 meeting with FDA, the subsequent studies were designed to
support a pathway forward to BLA in the US with both G309 and G306
studies including US subjects and it is
also planned to include US subjects in the upcoming paediatric
study G308. As previously communicated, a
specific requirement for FDA, will involve a further study known as
G307 to meet the required total number of US subjects treated using
the product intended for registration and the Group are planning
for meetings with the FDA to agree a route forward. Immediate
focus will be preparing the data package for national MAA in Q4
alongside exploration for potential collaborations for US
expansion.
Manuel Llobet, Chief Executive Officer of Allergy
Therapeutics, commented: "We appreciate the supportive
and helpful discussions with the PEI and are very pleased that
preparations for the regulatory submission of our Grass MATA MPL
immunotherapy candidate remain on track. Bringing Grass MATA MPL to
this stage has been a huge undertaking for a company like us. After
many years and significant investment, we are extremely encouraged
by the possibility of bringing this state-of-the-art vaccine to the
market, transforming the lives of millions of patients around the
world."
- 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 (Nominated Adviser and
Broker)
Emma Earl, Freddy Crossley, Mark
Rogers, Corporate Finance
Rupert Dearden, Corporate
Broking
+44 (0)20 7886 2500
ICR
Consilium
Mary-Jane Elliott / David Daley /
Davide Salvi
+44 (0)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. 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.
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.