Allergy Therapeutics (AGY), the specialist pharmaceutical company focused on allergy vaccination, announced 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 per cent (Germany) to 17.2 per cent (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 per cent of the AR population not diagnosed. 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."