Allergy Therapeutics PLC Positive data with house-dust mite immunotherapy

TIDMAGY

Allergy Therapeutics PLC

29 May 2018

Allergy Therapeutics plc

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

Positive new clinical data with house-dust mite immunotherapy

House-dust mite immunotherapy shown to be well-tolerated and demonstrates highly significant symptom improvement

Allergy experts present an overview of adjuvants at satellite symposium during EAACI 2018

29 May 2018 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces positive new data on its wholly-owned modified house-dust mite subcutaneous immunotherapy(1) . This data will be presented today at the 37(th) Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Munich, Germany.

The Group's modified house-dust mite product sold as through a Named Patient Program in Spain, is the precursor to the modified house-dust mite + MPL product currently in Phase I, as announced in February 2017.

In this observational study conducted in 10 sites across Spain, 141 patients were evaluated and demonstrated a 43% decrease in combined symptom medication score compared with baseline after one year (p = <0.0001). In addition, in a subgroup of asthmatic subjects, 16.7% of patients were observed with moderate persistent asthma at one year compared with 50.9% at baseline (p = <0.01). No patients presented with serious adverse events and no patients had to stop treatment due to any adverse event.

Allergy Therapeutics also presented a series of poster presentations at EAACI with key highlights including an overview of the early-phase pre-clinical developments for the Group's planned recombinant peanut vaccine(3) and a discussion of the results of a non-interventional study investigating rapid up-dosing of tree sublingual immunotherapy(4) .

Other events held by the Group at EAACI included a satellite symposium entitled: "Adjuvants through the ages"(2) which provided a summary of how adjuvant technologies have evolved and how Allergy Therapeutics is spearheading the design and testing of state of the art allergen-specific immunotherapies.

Manuel Llobet, Chief Executive Officer, commented: "We are excited to be sharing our latest research at EAACI, demonstrating the breadth of our unique allergen immunotherapy company. The positive new data on our modified house-dust mite immunotherapy and our recent announcement on the success of our Grass G205 dose-finding clinical study confirms that our novel allergen-specific immunotherapies are formulated to the optimal strength, and we believe Allergy Therapeutics has the potential to transform allergy treatment with optimised-dose, well-characterised, aluminium-free, convenient products."

For further information, please contact:

Allergy Therapeutics

[phone]

Manuel Llobet, Chief Executive Officer

Nick Wykeman, Chief Financial Officer

Panmure Gordon

[phone]

Freddy Crossley, Emma Earl, Corporate Finance

Consilium Strategic Communications

[phone]

Mary-Jane Elliott / Ivar Milligan / Philippa Gardner

[e-mail]

Stern Investor Relations, Inc.

[phone]

Christina Tartaglia

[e-mail]

Notes for editors:

About Allergy Therapeutics

Allergy Therapeutics is an international commercial biotechnology company focussed on the treatment and diagnosis of allergic disorders, including 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 include 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 double digit compound annual growth since formation, employs c.500 employees and is listed on the London Stock Exchange (AIM:AGY). For more information, please see www.allergytherapeutics.com.

About the modified mite MPL programme

House dust mite is the major cause of perennial allergic rhinitis and allergic asthma(6) . The modified house-dust mite + MPL product builds on the strong foundation of technologies employed in the successful Pollinex Quattro range of allergy immunotherapies. It is the only house-dust mite immunotherapy utilising MCT(R) (Microcrystalline Tyrosine), a natural, biodegradable depot, and the adjuvant MPL for the treatment of perennial allergic rhinitis which makes this vaccine unique in the $1.5 billion per year market(7) . The modified house-dust mite + MPL product is currently in phase I with an anticipated readout in Q1 2019. This is an exciting opportunity for the group to boost its addressable market.

About the Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI)

The EAACI Congress 2018 is a congress organised by the European Academy of Allergy and Clinical Immunology (EAACI) which offers a unique opportunity to learn about new discoveries and exchange experience with professionals in the field of allergy and clinical immunology. The Congress is taking place in Munich, Germany from 26-30 May 2018.

References

(1) A. Roger et al., Immunological and clinical changes after 1-year treatment with a tyrosine-adsorbed mite allergoid: preliminary results. EAACI 2018. PDS 30, Poster Discussion Zone 3. 29(th) May 2018 - 15:30-17:00

(2) Allergy Therapeutics Symposium. EAACI 2018. Adjuvants through the ages. Hall 13a, 27 May 2018, 17:30-19:00.

(3) M. F. Bachmann et al., Development of a recombinant vaccine based on virus-like particles for the treatment of peanut allergy. EAACI 2018. OAS 31, Hall 5. 29(th) May 2018 - 15:30-17:00

(4) N. Y. Breitruck et al., Rapid up-dosing in sublingual specific immunotherapy is well-tolerated and effective in patients suffering from tree pollen allergic rhinitis. EAACI 2018. TPS 16, Poster Area. 27(th) May 2018 - 12:00-13:30

(5) http://otp.investis.com/clients/uk/allergy_therapeutics/rns/regulatory-story.aspx?newsid=1021128&cid=1045

(6) Calderón M et al., Respiratory allergy caused by house dust mites: What do we really know? J Allergy Clin Immunol. 2015 Jul;136(1):38-48

(7) QYR Pharma report. September 2016

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May 29, 2018 02:01 ET (06:01 GMT)