REG - Allergy Therapeutics - Submission of MAA for Grass MATA MPL

Allergy TherapeuticsAnnouncement

25/11/2024 07:00

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RNS Number : 4106N  Allergy Therapeutics PLC  25 November 2024

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
(mailto: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 (http://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.

 

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