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RCS - Allergy Therapeutics - Allergy Therapeutics shares positive new data

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RNS Number : 1155D  Allergy Therapeutics PLC  01 March 2022

 

Allergy Therapeutics plc

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

 

Allergy Therapeutics shares positive new data at the 2022 American Academy of
Allergy Asthma and Immunology Annual Meeting

 

-     Five posters presented including highly successful results from
Grass MATA MPL G309 exploratory field trial and ex-vivo VLP001 biomarker study
examining potential of VLP Peanut

 

-     Data show clinically 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

 

-     Convincing data presented from VLP001 ex-vivo biomarker study show
VLP Peanut has potential to modulate T cell, B cell and dendritic cell
responses, promoting the protective tolerogenic pathway and highlighting the
potential as an effective treatment for peanut allergy

 

1 March 2022 Allergy Therapeutics plc (AIM: AGY), the fully integrated
commercial biotechnology company specialising in allergy vaccines, today
announces the presentation of positive new data from its two lead
immunotherapy programmes at the 2022 American Academy of Allergy Asthma and
Immunology Annual Meeting held in Phoenix, Arizona.

 

Allergy Therapeutics presented extensive results from the G309 exploratory
field trial demonstrating 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. This was a multi-centre, double-blind, placebo-controlled,
randomised and parallel-group clinical trial with subjects enrolled across 13
sites in Germany and the US.

 

·      The presentations revealed a more pronounced, clinically relevant
and statistically significant improvement in the primary combined symptom and
medication score compared to the historically used placebo group (used for
Phase II and planned for the upcoming pivotal Phase III study G306) - a 33.1%
(p=0.0325) and 39.5% (p=0.0112) effect size on the primary endpoint for the
conventional and extended posology groups, respectively.

 

·      This 39.5% improvement is higher than the 36.8% figure initially
reported by the Group in October 2021 where the two placebo groups were
combined. These results further highlight the superior treatment effect sizes
achieved after six injections of Grass MATA MPL.

 

·      The Group also presented post-hoc analyses of an earlier Phase II
grass trial highlighting the strong predictive value of the baseline CPT
(conjunctival provocation test) score for IgG4 increase after SCIT treatment,
providing a rationale for the design of the upcoming pivotal G306 Phase III
trial due to commence in the autumn of this year.

 

·      The Company also provided details of a pollen monitoring network
established by Allergy Therapeutics in the US, with central reading procedures
to accurately measure daily pollen counts and better establish the peak grass
pollen season - an important requirement for determining the primary study
results of the G306 Phase III trial.

 

Dr Mohamed Shamji, Reader in Immunology & Allergy, Imperial College
London, presented data from the VLP001 ex-vivo biomarker study investigating
the Group's peanut allergy vaccine candidate, VLP Peanut. The data presented
showed that VLP Peanut does not elicit an allergic reaction (i.e. it is
hypoallergenic) and results in a significant reduction in basophil activation
and histamine release from peanut allergic subjects, when compared to the
major allergen, Ara h2, and whole peanut extract. These biomarker results
provide strong confidence in the potential beneficial immunologic mode of
action of VLP Peanut in promoting class switching from the allergic Th2
pathway to the more tolerogenic Th1 pathway, underlining VLP Peanut's
potential as an effective treatment for peanut allergy.

 

Manuel Llobet, Chief Executive Officer, commented: "Demonstrating a nearly
40% reduction in combined symptom and medication score compared to placebo in
a grass pollen allergy trial is a significant event in our history. We are
very much looking forward to the pivotal G306 clinical trial of our Grass MATA
MPL immunotherapy that is due to commence later this year and, if successful,
would enable registration in Europe and the US. Such a product would permit
patients suffering from grass pollen allergy the opportunity to address the
cause of their disease, not just mask their symptoms. I am also very proud to
see the data from our VLP001 study being presented internationally - data that
provides us with confidence in the product profile of our novel short course
peanut allergy vaccine candidate as we head into the clinic later this year."

 

- 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

+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 the American Academy of Allergy Asthma and Immunology

 

The American Academy of Allergy, Asthma & Immunology (AAAAI) is the
leading membership organization of more than 7,000 allergists / immunologists
(in the United States, Canada and 72 other countries) and patients' trusted
resource for allergies, asthma, and immune deficiency disorders. The American
Academy of Allergy, Asthma & Immunology is dedicated to the advancement of
the knowledge and practice of allergy, asthma and immunology for optimal
patient care.

 

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 has
achieved over 9% compound annual growth since formation, employs c.600
employees and 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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