Allergy Therapeutics PLC Positive Efficacy & Safety Data in Peanut Vaccine (6674V)
February 01 2017 - 2:00AM
UK Regulatory
TIDMAGY
RNS Number : 6674V
Allergy Therapeutics PLC
01 February 2017
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(R) 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:
Allergy Therapeutics
+44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Nick Wykeman, Finance Director
Panmure Gordon
+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
allergytherapeutics@consilium-comms.com
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 billion(2) ,
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.
References
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
This information is provided by RNS
The company news service from the London Stock Exchange
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