REG - Allergy Therapeutics - Skin-prick testing completes in PROTECT Trial

Allergy TherapeuticsAnnouncement

19/04/2023 07:00

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RNS Number : 6628W  Allergy Therapeutics PLC  19 April 2023

 

 

Allergy Therapeutics plc

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

 

Allergy Therapeutics completes skin-prick testing in peanut allergic patients
in Phase I PROTECT Trial

 

-      Skin testing results among peanut allergic patients administered
VLP peanut via skin-prick testing (SPT) supports its safety protective
potential

-      Data enables progression to next phase of study where healthy
subjects are given increased subcutaneous doses of VLP Peanut

-      Short-course vaccine candidate VLP Peanut has the potential to
transform the current treatment paradigm of peanut allergy

 

19 April 2023 Allergy Therapeutics (AIM: AGY), the fully integrated commercial
biotechnology company specialising in allergy vaccines, today announces that
the first cohort of peanut allergic patients have successfully received the
Group's innovative, short-course peanut allergy vaccine candidate, VLP Peanut
via skin prick testing (SPT). The PROTECT trial is a first-in-human study
evaluating the safety and tolerability of VLP Peanut in healthy and peanut
allergic adult subjects.

 

Results of the open label phase of the PROTECT trial demonstrate a strongly
reduced skin testing reactivity of VLP peanut compared to a peanut extract and
enable the Group to progress to the second part of the Phase I study where
healthy subjects will receive ascending doses of the vaccine candidate
administered subcutaneously to further assess safety, prior to embarking on a
Phase I/IIa approach for subsequent blinded subcutaneous dose escalation in
peanut allergic subjects. Safety and tolerability data for healthy allergic
subjects receiving ascending doses of the vaccine candidate administered
subcutaneously is expected to be available in Q4 2023.

 

Manuel Llobet, CEO of Allergy Therapeutics, commented: "Peanut allergy is one
of the most common types of food allergies. For some people, even the smallest
amounts of peanuts can cause a potentially life-threatening reaction. With its
increasing prevalence, now more than ever, we need better treatment options
beyond the current approaches that require repeated and long-lasting exposure,
therefore limiting patient adherence, and not providing sustained protection
after stopping treatment.''

 

Allergy Therapeutics' wholly-owned, subcutaneous, recombinant vaccine
candidate incorporates novel virus-like particle (VLP) technology, which
enhances the body's immune response by making the peanut allergen resemble an
inactive virus. The vaccine candidate is based on immunologically optimised
cucumber mosaic virus-derived (CuMV(TT)) VLPs with the major peanut allergen
(Arachis hypogaea) (Ara h2) displayed on its surface. This engineered,
plant-based virus, is designed for enhanced safety and, provides a platform to
induce protective antibodies without replicating or infecting human cells,
similar to classic vaccination. This constitutes a step change in allergy
treatment when compared to current allergen-specific immunotherapy approaches.

 

About peanut allergy

Peanut allergy is one of the most common types of food allergy and its
symptoms can range from mild to severe and life-threatening. Its prevalence in
Western countries is on the rise and currently ranges from 1.4-3% of
children(1).

 

Peanut allergy affects around 2% of children in the UK and has been increasing
in recent decades. It usually develops in early childhood but can occasionally
appear in later life. Peanut allergy tends to be persistent and only
approximately 1 in 5 children outgrow their allergy, usually by the age of
10(2).

 

In the US, peanut allergy affects an estimated 1.2% of the overall US
population(3) with 1 in 4 children with a peanut allergy requiring a hospital
visit each year(4).

 

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

 

- ENDS -

 

References

 

1.   Nwaru BI, Hickstein L, Panesar SS, Muraro A, Werfel T, Cardona V, et
al. The epidemiology of food allergy in Europe: a systematic review and
meta-analysis. Allergy. 2014. 1;69(1):62-75. Available from: http://
(http://doi.wiley.com/10.1111/all.12305) doi.wiley.com/10.1111/all.12305
(http://doi.wiley.com/10.1111/all.12305)

 

2. https://www.allergyuk.org/resources/peanut-allergy-factsheet/
(https://www.allergyuk.org/resources/peanut-allergy-factsheet/)

 

3.
https://www.ajmc.com/journals/supplement/2018/managed-care-perspective-peanut-allergy/the-economic-impact-of-peanut-allergies
(https://www.ajmc.com/journals/supplement/2018/managed-care-perspective-peanut-allergy/the-economic-impact-of-peanut-allergies)
 

 

4.   Gupta RS, Warren CM, Smith BM, et al. The Public Health Impact of
Parent-Reported Childhood Food Allergies in the United States. Pediatrics.
2018;142(6):e20181235. Available from:
https://www.ncbi.nlm.nih.gov/pubmed/30455345
(https://www.ncbi.nlm.nih.gov/pubmed/30455345)

 

 

For further information, please contact:

 

Allergy Therapeutics

+44 (0) 1903 845 820

Manuel Llobet, Chief Executive Officer

Martin Hopcroft, Interim 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

 

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.

 

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