Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")
Positive Efficacy and Safety Data Shown in Peanut Allergy Vaccine
1 February 2017 Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces positive results from preclinical research into its unique therapeutic peanut allergy vaccine, Polyvac® Peanut. Having delivered these positive preclinical Proof of Concept results, Allergy Therapeutics will now progress the vaccine in accordance with its stated strategic plan when funding the programme and will proceed to Phase I development following completion of a first in man safety data trial.
The findings demonstrate that a single dose of the Company's virus-like-particles (VLP) adjuvant combined with recombinant peanut allergen successfully protected against anaphylaxis when challenged with peanut. Additionally, when examining symptom scores in the investigational model, those vaccinated with the candidate vaccine exhibited no symptoms compared to placebo. Furthermore, the safety profile of the product was evaluated via an intravenous challenge and found that the vaccine itself did not induce anaphylaxis in peanut sensitised subjects (a hypoallergenic vaccine).
Allergy Therapeutics' innovative peanut vaccine is focussed on a subcutaneous application of recombinant peanut allergen coupled with its state-of-the-art VLP adjuvant to increase the safety and efficacy profile. This approach aims to induce protective immunity, enabling shorter therapy duration and an enhanced safety profile and thus has significant implications for peanut allergy therapy with the potential to redefine the market for food allergy products. Alternative peanut vaccines in development often require repeated and long-lasting exposure transdermally or orally which may limit patient adherence.
Food allergy represents a significant and strategically important area for the Company, with peanut allergy treatments alone being an $8 billion p.a. addressable market globally. Allergy Therapeutics has the exclusive rights to develop VLP technology, a carrier system to present allergens to the immune system, for allergy vaccines.
Allergy Therapeutics intends to publish full data from this study in a peer-reviewed journal.
Commenting on the data, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "Part of our international growth strategy has been to expand our immunotherapy platforms into other indications to widen our total addressable market. Consequently, whilst recognising the early stage nature of this project, we are extremely encouraged by these results. The data clearly demonstrate that when our unique adjuvant is coupled with recombinant peanut allergen it provides protection against anaphylaxis and also indicated no safety concerns often associated with traditional injected peanut vaccines. Hundreds of patients die each year in the United States as a result of food allergies (mainly peanut) and we are committed to saving these lives. This peanut vaccine programme complements our current range of marketed ultra-short course vaccines in terms of safety, efficacy and improved patient convenience."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
For further information, please contact:
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Finance Director
+44 (0) 20 7886 2500
Freddy Crossley / Duncan Monteith, Corporate Finance
Tom Salvesen, Corporate Broking
Consilium Strategic Communications
+44 20 3709 5700
Mary-Jane Elliott / Ivar Milligan
Notes for editors:
Unmet need in peanut allergy
Anaphylaxis caused by peanut allergy is a potentially life-threatening event, and is the most common food allergy, with typical prevalence of 0.5% to 1%1. Currently, the only available treatment is strict peanut avoidance and patients are required to self-administer epinephrine upon accidental exposure as there is no approved vaccine or treatment. This is of great concern to patients as accidental exposure to peanut can cause severe anaphylaxis and thus an effective treatment for peanut allergy is highly sought-after. The market is estimated to be worth $8 billion2, and success of a peanut vaccine would significantly boost Allergy Therapeutics addressable market.
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.
1. R.S. Gupta, et al. The prevalence, severity, and distribution of childhood food allergy in the United States. Pediatrics, 128 (2011), pp. e9-e17
2. The Journal of Allergy and Clinical Immunology 2016. 1% of US population. EACCI Food Allergy and Anaphylaxis Guidelines Group 2016 0.2% of Western European Population. Management assumption of annual treatment of $2k