REG - Allergy Therapeutics - G306 Phase III trial meets key endpoints

Allergy TherapeuticsAnnouncement

13/12/2023 07:15

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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
(mailto: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
(http://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 (https://clinicaltrials.gov/ct2/home) under the identifier
NCT05540717 (https://clinicaltrials.gov/ct2/show/NCT05540717) .

 

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