Allergy Therapeutics PLC Successful meetings with Paul Ehrlich Institut

RNS Number : 7474Q

Allergy Therapeutics PLC

03 June 2024

 

 

 

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

[phone]

 

Panmure Gordon (Nominated Adviser and Broker)

Emma Earl, Freddy Crossley, Mark Rogers, Corporate Finance

Rupert Dearden, Corporate Broking

[phone]

 

ICR Consilium

Mary-Jane Elliott / David Daley / Davide Salvi

[phone]

[e-mail]

 

 

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.

 

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