Allergy Therapeutics PLC Announces Novel House Dust Mite Allergy Vaccine Gains Clinical Trial Application Approval

CTA approval in Spain for Phase I AM101 clinical study evaluating safety of adjuvanted, modified house dust mite allergy vaccine

WORTHING, UK I February 14, 2017 I Allergy Therapeutics ( AIM : AGY ), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces that the Phase I clinical study investigating the safety and tolerability of Acarovac MPL (monophosphoryl lipid A) has received Clinical Trial Application (CTA) approval in Spain.

House dust mites are a major cause of perennial allergic rhinitis and allergic asthma1. Acarovac MPL builds on the strong foundation of technologies employed in the successful Pollinex® Quattro range of subcutaneous allergy immunotherapies, and builds on the demonstrated efficacy2 of the existing successful product platform of Acarovac Plus™, the fastest growing "named-patient product" in Allergy Therapeutics' Spanish subsidiary. Acarovac MPL is the only house-dust mite immunotherapy in development utilising MCT® (microcrystalline tyrosine), a natural, biodegradable depot, and the adjuvant MPL for the treatment of perennial allergic rhinitis making this vaccine unique in a $1.5 billion per annum market3.

CTA approval has been granted and the Company now expects this formulation to begin Phase I studies immediately, to assess the safety and tolerability of two different dose regimens. Both treatment regimens include a two-to-four week initial up-dosing phase but differ in the duration of the later maintenance phase. The Phase I trial of 32 patients is expected to last one year, and to be delivered on-time in-line with the Company's stated strategic plan when funding the programme in November 2015. If the Phase I trial is successful, the Company expects to launch Acarovac MPL in Spain on a named-patient basis.

Commenting on the CTA approval, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "By using the successful biodegradable adjuvant system of MCT® and MPL, integral in our seasonal marketed vaccines, in a perennial house dust mite vaccine, we aim to improve both safety and efficacy for the thousands of patients who suffer year-round due to house dust mite allergy. Acarovac Quattro will provide convenience to our patients and doctors and more efficient pharmacoeconomics. Effectively, the dosing regime in Acarovac Quattro has the potential to improve the convenience, adherence and compliance that is essential for a successful treatment, and builds on the acceptance of the existing Acarovac Plus platform."

Notes for editors:

About Allergy Therapeutics
Allergy Therapeutics is an international specialty pharmaceutical company focussed on the treatment and diagnosis of allergic disorders including immunotherapy vaccines that cure disease. The Company sells proprietary products and third party products from its subsidiaries in nine major European countries and via distribution agreements in an additional ten countries.

Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is headquartered in Worthing, UK with MHRA-approved manufacturing facilities. The Company employs c.495 employees and is listed on the London Stock Exchange ( AIM : AGY ). For more information, please see www.allergytherapeutics.com.

References
1. 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
2. Roger, A., Depreux, N., Jurgens Y., Heath M, Garcia G., Skinner M, A novel and well tolerated mite allergoid subcutaneous immunotherapy: Evidence of clinical and immunologic efficacy. Immunity, Inflammation and Disease, 2014; 2 (2); 92-98
3. QYR Pharma report. September 2016

SOURCE: Allergy Therapeutics

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