European Patent Granted

RNS Number : 1256W

Allergy Therapeutics PLC

23 July 2009

 



23 July 2009

Allergy Therapeutics plc

("Allergy Therapeutics" or "the Company")

European Patent Granted For MPL-Based Sublingual Vaccines

Allergy Therapeutics (AGY), the specialist pharmaceutical company focused on allergy vaccination, announces that the European Patent office has granted a broad technology patent relating to the Company's family of MPL®-based sublingual allergy vaccines. This patent (jointly held with Corixa Inc) covers the use of glycolipid adjuvant administered sublingually with one or more antigens for use in the treatment of allergy or other diseases (infections, cancer or autoimmunity). 

Allergy Therapeutics' new generation of allergy vaccines use MPL®, an innovative TLR4-agonist, as an adjuvant to boost and accelerate the immune response of an allergy vaccine.  Allergy Therapeutics has already conducted and previously reported results of a double-blind, placebo controlled, dose ranging Phase IIa MPL-based oral allergy vaccine study. The study (Study 103) was conducted in 80 grass-sensitive human subjects and involved the addition of MPL to Allergy Therapeutics' ORALVAC® grass pollen vaccine. This was the first time that any adjuvant had ever been clinically tested in an oral allergy vaccine and was also the first ever examination of oral delivery of MPL in humans. The results demonstrated that the vaccine was well tolerated and that, following an eight week treatment period, clinical symptoms improved and were accompanied by a characteristic pattern of immune response. 

Datamonitor estimates that the prevalence of allergic rhinitis ("AR") varies from 9.2% (Germany) to 17.2% (France) and that in the five major European markets the diagnosed AR population over 20 years of age is 28.3 million. However, under-diagnosis is substantial, with an estimated 44% of the AR population not diagnosed1. The value of the immunotherapy market in Europe is estimated to be more than €550 million.

The development of a convenient, effective, short course, well tolerated oral allergy vaccine would have significant implications for allergy therapy and redefine the market for allergy products. Currently available oral allergy vaccines require prolonged treatment periods associated with poor patient compliance and low efficacy.  

Tom Holdich R&D Director of Allergy Therapeutics, said: "This patent recognises the unique potential benefit of the oral administration of MPL-based vaccines. Although sublingual allergy vaccines have been available for many years, the correct balance of efficacy, safety and convenience has been elusive. MPL has the ability to transform sublingual immunotherapy as it has done with subcutaneous immunotherapy." 

 For further information

Allergy Therapeutics Keith Carter, Chief Executive Tom Holdich, R&D Director	[phone]
Nomura Code Securities Juliet Thompson/ Clare Terlouw	[phone]
Financial Dynamics Ben Brewerton/ Sue Quigley	[phone]

1 Datamonitor, Immunotherapy in Allergic Rhinitis, (Published 03/2006, ref.DMHC2206)

About ORALVAC® and MPL 

ORALVAC is a sublingual immunotherapy containing standardized aqueous allergen extracts administered under the tongue as a metered dose. Altogether 17 different allergens (pollens, mites, epithelia and moulds) are available in ORALVAC and up to 4 may be mixed in an individual formulation. The product has been available for 'named patient' use since 1994 and to date it is estimated that approximately 100,000 patients have received treatment. The ORALVAC Compact formulation has recently been launched in Germany and allows for the maintenance dose to be reached on the first day of treatment.

MPL (monophosphoryl lipid A) is a Toll-Like 4 Receptor (TLR4) agonist and has been extensively tested in Pollinex Quattro and other late stage and registered vaccines including GlaxoSmithKline's Fendrix® and Cervarix®.

About Seasonal Allergic Rhino-conjunctivitis

Seasonal allergic rhino-conjunctivitis is commonly referred to as hayfever when it is caused by pollen. It is a widespread condition that usually occurs during the pollen season.  It is characterized by sneezing, rhinorrhea, nasal congestion and pruritus of the nose, eyes or throat. It is a type I hypersensitivity response in which allergen binds to immunoglobulin E on the surface of mast cells. This response leads to the release of histamine, prostaglandins and leukotrienes, which cause the inflammation, itching and redness.

About Allergy Vaccination

Allergy vaccination or immunotherapy is an effective way of modifying or avoiding disease by influencing the immune system. It reinforces the body's own defence mechanisms and is similar to preventative vaccination against infectious disease.  In allergy vaccination the mechanism is regarded as a correction of the immune system towards a more normal, non-allergic, response.

Allergy vaccination addresses the underlying cause of the problem and provides a patient benefit which is usually long lasting. The World Health Organisation recognises allergy vaccination as the only treatment to target the immunological cause of allergy with the ability to modify disease progression (to more severe allergy and to asthma), decreasing symptoms in the short term and offering long term anti-inflammatory benefits which prevent the development of persistent disease. Allergy vaccination, therefore, has the potential of offering patients a cure for their disease.

About Allergy Therapeutics

Allergy Therapeutics plc is a London Stock Exchange (AIM) listed, integrated specialist pharmaceutical company focused on allergy vaccination. It has a growing, profitable core business achieving sales of allergy vaccines of £31 million in Germany, Italy, Spain and other EU markets through its own sales and marketing infrastructure. The Company is expanding its infrastructure with operations also in the United Kingdom, Poland, the Czech Republic, Slovakia and Austria.

Full Details of Study 103

The purpose of Study 103 was to investigate the potential contribution of MPL when administered orally for the first time as part of a sublingual vaccine.

Study 103 was a double-blind placebo-controlled safety study evaluating different doses of MPL and grass pollen allergen involving 4 groups of 20 grass pollen sensitive subjects (16 active plus 4 placebo per group). Subjects self administered the liquid sublingual vaccines daily for 8 weeks and assessments were made during and 2 weeks after the dosing period. Group 1 received Allergy Therapeutics' Oralvac Plus grass pollen vaccine; Group 2 received a similar vaccine incorporating a low dose of MPL and Group 3 likewise but with a higher dose of MPL. Group 4 received the higher dose of MPL but with a higher grass pollen allergen dose. Comparisons were made with the overall number of patients on placebo (n=16).  

The primary objective of the study was safety and tolerability. Throughout the study, all vaccines were well tolerated with no patients withdrawn due to adverse events and no reports of serious or severe adverse events. The nature of adverse events was as expected with slightly more patients reporting transient mild itching in the mouth during the first couple of days on active treatment compared to placebo. There was no evidence of any adverse effect associated with the use of MPL.

The secondary objective of the study was to investigate the contribution of MPL to the activity of the vaccines as measured by clinical (nasal challenge) and immunological (IgG, IgG1, IgG4 and IgE) parameters.

The nasal challenge test involved the objective measurement of nasal airflow, together with assessment of nasal secretions and irritation and other non-nasal symptoms, at 10, 20 and 30 minutes after allergen was sprayed into the nose. A negative test indicates minimum reaction to the allergen challenge throughout. Groups 3 and 4 (high dose MPL) show a notably greater proportion of patients with a negative nasal challenge compared to placebo (44% vs 19%) following treatment (ITT). A further analysis indicates that Groups 3 and 4 show a statistically significant improvement in nasal challenge over placebo combined with Groups 1 and 2 (low dose MPL) (p<0.05).

In terms of immune response, all the active treatment groups showed an increase in median IgG following treatment, yet with Groups 3 and 4 this rise was evident earlier, after 3 to 5 weeks of treatment. Regarding the IgG subclasses, an increase in IgG4 in particular seemed to be associated with the addition of MPL. As would be expected with allergy vaccination, a rise in IgE was also associated with active treatment; however, the rise in IgE was lowest with the higher MPL dose Groups 3 and 4.

In summary, the results from Study 103 indicated a pattern of response with the oral administration of MPL that matched that already experienced with subcutaneous administration - a stimulation of immune response accompanied by clinical benefit. 

 

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