Allergy Thera. Regulatory News (AGY)

6 July 2015

Allergy Therapeutics plc

("Allergy Therapeutics" or "the Company")

Positive Dust Mite Study Results

Allergy Therapeutics, the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces positive results from its prospective observational Acarovac Plus clinical study for the treatment of house dust mite allergy. Acarovac Plus is being developed as one of the Company's new generation of products to address the perennial allergy market with innovative and short-course therapies.

At the Adjuvants in Allergy conference over the past weekend, Dr. Albert Roger, Director of the Allergy Unit at Universitari Hospital Germans Trias Pujol, Badalona Spain, presented the results of a prospective observational one-year follow-up study, comparing the safety, tolerability and long-term effectiveness of Acarovac Plus using Dermatophagoides pteronyssinus (house dust mite) in 30 adult patients with allergic rhinitis and/or asthma. Acarovac Plus has been designed to administer maintenance doses every 6-8 weeks, reducing the number of annual injections required and providing a natural, biodegradable, alternative depot1 vaccine.

Tolerability of Acarovac Plus was demonstrated with no reported adverse events. The effectiveness of Acarovac Plus was measured in patients using a nasal provocation test, which evaluates the sensitivity of each patient to mite allergens. Nasal airway assessments were performed using peak nasal inspiratory flow measurements. In summary, a reduction in symptom scores of >50% were observed during follow up visits after one year. Immunological markers were also assessed and showed significant improvements in antibody IgG4 and anti-inflammatory IL-10 molecules, indicating tolerance induction in patients after one year of treatment.

A validated patient satisfaction survey provided information that was reflective of the clinical findings from the study. A high degree of overall patient satisfaction was observed, which encompassed significant improvements in scores after one year in relation to overall effectiveness and convenience of the treatment. This reinforces one of the main objectives of Allergy Therapeutics in improving patient life by producing effective treatments, while at the same time reducing the discomfort of injections, improving compliance and adherence of allergy immunotherapy products.

Further to the efficacy noted for Acarovac Plus2, Allergy Therapeutics is developing Acarovac Quattro, an ultra-short course therapy utilising the adjuvant monophosphoryl lipid A (MPL), which is used in the Company's successful Pollinex Quattro product range currently in late stage development in Europe and the US.

Dr Roger, principal investigator for the study, said:

"The successful clinical results in the one year follow-up study clearly demonstrate the effective treatment of house dust mite allergy by Acarovac Plus. We also observed significant decreases in symptom scores and improvement in nasal sensitivity immediately after the up dosing phase of one month. Acarovac Plus therapy not only led to a high rate of patient satisfaction early in treatment, but also the convenient maintenance regime of injections every 6 weeks has the potential to improve the adherence and compliance with the vaccine regime that is essential for a successful treatment."

Manuel Llobet, Chief Executive Officer, commented:

"Following the continued successful development of the Pollinex Quattro product range addressing the seasonal segment of the allergy market, we now intend to extend this innovative franchise into developing perennial allergy vaccines. On the back of these promising results for Acarovac Plus in ameliorating the symptoms of house dust mite allergy, we have embarked on the development of an ultra-short course version utilising the adjuvant MPL. We expect that Acarovac Quattro will have all the benefits of both Pollinex Quattro technology platform coupled with the efficacy seen with Acarovac Plus. Over 20% of the population in both Europe and the US have an allergic reaction to house dust mites and so an effective short course allergy vaccine will be an important and potentially valuable addition to our product range"

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About Allergy Therapeutics

Allergy Therapeutics is a specialty pharmaceutical company focused on allergy vaccination. It has a growing business achieving revenue in the last financial year of £42 million mainly in Europe through its own sales and marketing infrastructure and further afield through distributors.

Acarovac Plus

Acarovac Plus has been Allergy Therapeutics strongest growing treatment in Spain this year and it is being developed as one of the Company's new generation of products developed to address the perennial allergy market with innovative and short-course therapies.

Acarovac Quattro 

Pollinex Quattro is the only ultra-short course immunotherapy utilising MPL (Monophosphoryl Lipid A) and MCT (Microcrystalline Tyrosine), a natural, biodegradable depot adjuvant for the treatment of seasonal allergic rhinitis. Building on the principles of the Pollinex Quattro formulation, Allergy Therapeutics have developed controlled and standardised allergoids for the treatment of perennial allergic conditions, such as house dust mite combined with MCT, which is already available for the treatment of dust mite allergy in parts of Europe (Acarovac Plus). Based upon the efficacy noted for Acarovac Plus2, an alternative ultra-short course therapy utilising MPL is being developed.

References

1. An injection, usually subcutaneous or intramuscular, of a pharmacological agent, which releases its active compound in a consistent way over a long period of time

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