Allergy Thera. Regulatory News (AGY)

27 January 2014

Allergy Therapeutics plc

("Allergy Therapeutics" or the "Company")

Short course immunotherapy effective in reducing ragweed pollen allergy

Results published in The Journal of Allergy and Clinical Immunology

Allergy Therapeutics, the fully integrated specialty pharmaceutical company announces that a paper entitled "Efficacy of a short course of specific immunotherapy in patients with allergic rhinoconjunctivitis to ragweed pollen" is now available in the January print edition of The Journal of Allergy and Clinical Immunology,1 the peer reviewed, high impact journal. The trial was conducted between May 2005 - Jan 2006.

This paper reports the full results of a large successful phase IIb clinical trial in which an ultra-short course (only 4 subcutaneous injections) of Allergy Therapeutics' Pollinex Quattro® Ragweed (Ragweed MATA MPL, a short ragweed pollen allergoid adsorbed to L-Tyrosine and MPL (monophosphoryl lipid A), 0.5ml) was shown to be safe and effective in reducing the common symptoms induced by an allergic response to ragweed pollen. Ragweed sensitivity is very common in the United States. In the National Health and Nutrition Examination Surveys NHANES III study 50.3% of the US population sampled had a positive skin test to allergens and 26.2% of these were sensitive to Ragweed.  

The randomized, double-blind, placebo controlled study evaluated the clinical efficacy and safety of Ragweed MATA MPL compared with placebo in reducing allergic rhinoconjunctivitis symptoms caused by ragweed pollen in an environmental exposure chamber (EEC) 3 weeks after treatment. Two hundred and twenty-eight Canadian patients with ragweed allergy received 4 weekly injections of active treatment or placebo. Total nasal and non-nasal symptom scores were obtained in the EEC before and three weeks after treatment. Mean improvement in total symptom scores (TSS - sum of individual scores for nasal symptoms and non-nasal symptoms) in the Ragweed MATA MPL group was statistically significantly greater than in the placebo group (relative mean improvement of active vs placebo, 48%; P < 0.05; whilst the median improvement relative to placebo was 82%).

The treatment was very well tolerated in the study. The majority of adverse events (AEs) experienced by subjects were mild injection-site reactions, commonly seen with this class of drug. Importantly, no severe systemic AEs or serious AEs occurred during the trial or have been reported subsequently.

Professor Tim Higenbottam, Allergy Therapeutics' R&D Director, commented, "The results detailed in this highly respected journal demonstrate that Pollinex Quattro® Ragweed could revolutionise treatment for ragweed related allergic rhinitis, by providing an effective, fast-acting treatment. The clinically observed administration mitigates poor adherence that is common in prolonged courses of treatment. Our four pre-seasonal allergy vaccine subcutaneous injections administered over a month make this product, produced under GMP, an attractive alternative to the lengthy course of injections or sublingual treatments that must be administered over periods of up to three years that are currently available with other allergen extract preparations."

The full abstract of the paper can be accessed by following this weblink: http://www.jacionline.org/article/S0091-6749(13)00907-X/abstract 

1 Piyush Patel, MD, Tom Holdich, MBBS, Karl J. Fischer von Weikersthal-Drachenberg, MD, and Birgit Huber, PhD. J Allergy Clin Immunol. 2014 133(1):121-129.e2.

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About Allergy Therapeutics

Allergy Therapeutics is a specialty pharmaceutical company focused on allergy vaccination. It has a growing business achieving sales in the prior financial year of £39.3 million mainly in Europe through its own sales and marketing infrastructure and further afield through distributors. The Company is expanding its infrastructure into the Emerging Markets.

Allergy Therapeutics has long been a pioneer for short course vaccines to facilitate patient adherence to therapy.