REG - Allergy Therapeutics - Key updates on Grass MATA MPL and VLP Peanut

Allergy TherapeuticsAnnouncement

08/12/2022 07:00

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RNS Number : 9931I  Allergy Therapeutics PLC  08 December 2022

 

Allergy Therapeutics plc

("Allergy Therapeutics", "ATL" or the "Group")

 

Allergy Therapeutics announces key updates on Grass MATA MPL

and VLP Peanut clinical programmes

 

Update on production and funding

 

-       Innovative short-course grass pollen immunotherapy with
best-in-class potential

-     If successful, Grass MATA MPL will be the first subcutaneous and
aluminium‑free short-course allergy immunotherapy approved in the US

-       Topline safety & efficacy data for Grass MATA MPL expected Q4
2023

-       Safety, tolerability and efficacy data for VLP peanut expected 2023

 

8 December 2022 Allergy Therapeutics (AIM: AGY), the fully integrated
commercial biotechnology company specialising in allergy vaccines, today
announces that the first subject has been dosed in the pivotal Phase III G306
trial, to evaluate the efficacy and safety 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.

 

Grass MATA MPL incorporates MicroCrystalline Tyrosine ("MCT(®)") adsorbed
allergoids, and the innovative adjuvant Monophosphoryl-lipid A ("MPL"). This
innovative technology only requires patients to receive six injections prior
to the grass allergy season to be protected.

 

The pivotal Phase III G306 trial is a multi-centre, randomised, parallel
group, double-blind, placebo-controlled clinical trial to confirm the efficacy
and safety of Grass MATA MPL. The clinical trial will be conducted in the US
and Europe at approximately 120 clinical trial sites. Data readout is planned
for Q4 2023.

 

Previously announced top-line results from the G309 exploratory field
trial showed meaningful and statistically significant reductions in symptoms
due to grass pollen allergy and in the use of relief medications after six
SCIT injections with Grass MATA MPL during peak grass pollen season.

 

In addition, the first subjects have been screened and are poised to receive
the Group's innovative, short-course peanut allergy vaccine candidate, VLP
Peanut in the Phase I PROTECT trial. The first-in-human study is evaluating
the safety and tolerability of VLP Peanut in healthy and peanut allergic adult
subjects and exploring preliminary proof of efficacy. Plans remain on track
for data in 2023.

 

Update on production and funding

 

Further to the announcement on the 28(th) October, work is continuing on cost
control and tight capital management following the impact of the pause in
production. This includes reviewing all funding options and managing the
working capital of the Group.

 

Manuel Llobet, CEO of Allergy Therapeutics, commented: "The start of our
pivotal Phase III G306 trial investigating the efficacy and safety of our
Grass MATA MPL marks the culmination of our efforts to bring this innovative
treatment to millions of patients affected by grass allergies in both the US
and Europe. We were encouraged by the results of our short-course grass pollen
immunotherapy in the highly successful G309 exploratory field trial and look
forward to advancing the development of this innovative treatment. The start
of the VLP Peanut PROTECT trial is a significant milestone and a testament to
the hard work of the Allergy Therapeutics team, developing innovative
approaches that have the potential to transform the way we treat and manage
allergies."

 

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) .

 

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.

 

This announcement contains inside information for the purposes of Article 7 of
Regulatory (EU) No596/2014.

 

- ENDS -

 

 

For further information, please contact:

 

Allergy Therapeutics

+44 (0) 1903 845 820

Manuel Llobet, Chief Executive Officer

Nick Wykeman, Chief Financial Officer

 

Panmure Gordon (Nominated Adviser and Broker)

+44 (0) 20 7886 2500

Freddy Crossley, Emma Earl, Corporate Finance

Rupert Dearden, Corporate Broking

 

Consilium Strategic Communications

+44 20 3709 5700

Mary-Jane Elliott / David Daley / Davide Salvi

allergytherapeutics@consilium-comms.com
(mailto:allergytherapeutics@consilium-comms.com)

 

Stern Investor Relations, Inc.

+1 212 362 1200

Christina Tartaglia

christina@sternir.com (mailto:christina@sternir.com)

 

 

Notes for editors:

 

About Allergy Therapeutics

Allergy Therapeutics is an international commercial biotechnology company
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 and house dust mite, and peanut allergy vaccine in
pre-clinical development. Adjuvant systems to boost performance of vaccines
outside allergy are also in development.

 

Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is
headquartered in Worthing, UK with more than 11,000m(2) of state-of-the-art
MHRA-approved manufacturing facilities and laboratories. The Group, which
employs c.600 employees, is listed on the London Stock Exchange (AIM:AGY). For
more information, please see www.allergytherapeutics.com
(http://www.allergytherapeutics.com) .

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