Allergy Therapeutics PLC Positive top line phase I results for Acarovac MPL (4837Z)

TIDMAGY

RNS Number : 4837Z

Allergy Therapeutics PLC

20 May 2019

Allergy Therapeutics plc

("Allergy Therapeutics" or the "Group")

Allergy Therapeutics announces positive top line results from Phase I clinical study using Acarovac MPL

- Investigational house dust mite allergy vaccine demonstrates good safety and tolerability profile

- Patients experienced symptom improvement in response to Nasal Provocation Testing

20 May 2019 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces positive Phase I safety and tolerability results of subcutaneous Acarovac MPL (Monophosphoryl Lipid A) in patients with house dust mite (HDM)-induced allergic rhinoconjunctivitis. The AM101 trial was an open-label study to assess the safety and tolerability of Acarovac MPL in 16 adult patients with house dust mite-mediated allergic rhinoconjunctivitis.

The primary endpoint was the safety and tolerability of 7 injections of Acarovac MPL administered over 6-12 weeks each 1-2 weeks apart. The formulation was well tolerated. The safety profile was satisfactory and the reported adverse events were consistent with what have been observed with similar formulations of allergy vaccines.

Secondary endpoints included the effect of treatment on response to nasal provocation test (NPT), immunological parameters including immunoglobulins and patients' satisfaction with the treatment. A significant improvement from baseline in patients' total symptom scores following NPT after 12 weeks, and significant increases in immunoglobulin markers and reduction in IL-4 were observed. Patients reported high satisfaction with their treatment measured via the ESPIA questionnaire (Satisfaction Scale for Patients Receiving Allergen Immunotherapy).

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "The success of our clinical trial in house dust mite-induced allergic rhinitis is encouraging news for the many patients who continue to suffer with the symptoms caused by house dust mite allergy, and supports our ambition to provide a global therapy for the important US, China and EU markets. Based on the unique triple-combination of our allergoids, and the adjuvant system MPL and MCT we believe Acarovac MPL could build on our success in dust mite immunotherapy and we look forward to progressing towards phase II clinical studies."

Acarovac MPL is a subcutaneous immunotherapy product containing Dermatophagoides pteronyssinus and Dermatophagoides farinae allergoids adsorbed to the adjuvant system comprised of MCT(R) (Microcrystalline Tyrosine) and MPL.

- ENDS -

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

Erik Anderson, Corporate Broking

Consilium Strategic Communications

[phone]

Mary-Jane Elliott / David Daley / Nicholas Brown / Olivia Manser

[e-mail]

Stern Investor Relations, Inc.

[phone]

Christina Tartaglia

[e-mail]

Notes for editors:

About Acarovac MPL

House dust mite is the major cause of perennial allergic rhinitis and allergic asthma([1]) . Acarovac MPL 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 the adjuvant system comprised of 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 ([2]) .

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 include vaccines for grass, tree and house dust mite, and peanut allergy vaccine in pre-clinical development. Other 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.

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] QYR Pharma report. September 2016

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May 20, 2019 02:00 ET (06:00 GMT)