Allergy Thera. Regulatory News (AGY)

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 (CuMVTT) 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 children1.

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 102.

In the US, peanut allergy affects an estimated 1.2% of the overall US population3 with 1 in 4 children with a peanut allergy requiring a hospital visit each year4.

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://doi.wiley.com/10.1111/all.12305

2. 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 

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

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.