Allergy Therapeutics
plc
("Allergy
Therapeutics" or "the Group")
Allergy Therapeutics Submits
Marketing Authorisation Application for Grass MATA MPL
to the Paul Ehrlich Institut in Germany
· Marketing Authorisation
Application for Grass MATA MPL submitted to
the Paul Ehrlich Institut, Germany under a national registration
procedure
· Regulatory submission based
on a comprehensive data package including the pivotal Phase III
G306 clinical trial
· Marketing Authorisation
Application to undergo review by the
Paul Ehrlich Institut once the submission has been
validated
25
November 2024 Allergy Therapeutics
(AIM: AGY), the fully integrated commercial biotechnology company
specialising in allergy immunotherapy announces that it has
submitted a full Marketing Authorisation Application (MAA) to the
Paul Ehrlich Institut (PEI) for its Grass MATA MPL
subcutaneous immunotherapy (SCIT) candidate designed to
address the cause of symptoms of allergic
rhinoconjunctivitis due to grass pollen.
The application has been submitted
under a National procedure in Germany and
following completion of standard validation checks by PEI, the
Group expects the formal MAA review process to begin
shortly.
Grass MATA MPL incorporates
MicroCrystalline Tyrosine ("MCT®")
adsorbed allergoids and the innovative adjuvant
Monophosphoryl-lipid A ("MPL"). Grass MATA MPL has been developed
to modify the allergic response following only six injections prior
to the grass allergy season.
The full MAA comprises a
comprehensive evidence package of quality, safety and clinical
efficacy including the Group's pivotal Phase III G306 trial in
adults. In that trial, Grass MATA MPL demonstrated a highly
statistically significant reduction in the Combined Symptom &
Medication Score (CSMS) compared to placebo over the peak pollen
season.
Manuel Llobet, CEO of Allergy
Therapeutics, commented: "The submission of the MAA to
the PEI in Germany marks a significant milestone in our regulatory
pathway, and brings us closer to potentially offering an important
new treatment option for patients affected by seasonal grass
allergy. We look forward to continuing to work closely with the PEI
during the review process of the MAA and I would like to thank the
team at Allergy Therapeutics for their dedication in advancing this
innovative product toward market."
- ENDS -
For
further information, please contact:
Allergy Therapeutics
Manuel Llobet, Chief Executive
Officer
Shaun Furlong, Chief Financial
Officer
+44 (0)1903 845 820
Cavendish Capital Markets Limited (Nominated Adviser and
Broker)
Geoff Nash /Giles Balleny/ Seamus
Fricker / Rory Sale
Nigel Birks - Life Science Specialist
Sales
Tamar Cranford Smith -
Sales
+44 (0)20 7220 0500
ICR
Healthcare
Mary-Jane Elliott / David Daley /
Davide Salvi
+44 (0)20 3709 5700
allergytherapeutics@icrhealthcare.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 immunotherapies 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 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 to form allergoids
that reduces 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
microcrystalline 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.