Allergy Thera. Regulatory News (AGY)

18 Apr 2007 07:01

Allergy Therapeutics PLC18 April 2007 Wednesday 18 April 2007 Allergy Therapeutics plc Announces Conclusive Results Of Oral Allergy Vaccine Study Promising Preliminary Results Reinforced In High Allergen Dose Group Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical companyfocussed on allergy vaccination announces the successful conclusion of its PhaseIIA oral allergy vaccine study following on a December announcement of promisinginitial data. That earlier announcement was based on the preliminary data fromthree study groups and today's announcement gives further details plus the datafrom a fourth study group that received a higher dose of grass pollen allergen. Allergy Therapeutics' new generation of allergy vaccines use MPL(R) aninnovative TLR4-agonist as an adjuvant to boost and accelerate the immuneresponse of an allergy vaccine. This study (Study 103) recorded a number offirsts. It was the first ever examination of oral delivery of MPL in humans andit was the first time that any adjuvant has ever been clinically tested in anoral allergy vaccine. The study showed that: • The vaccine was safe and well tolerated • Clinical symptoms improved following an eight week treatment period • Immunological response was noted following an eight week treatment period • Efficacy results follow a MPL dose dependant pattern Fuller analysis of the data has given Allergy Therapeutics further confidencethat it can develop an effective, rapid-onset, orally delivered allergy vaccine. As a next step, the Company is discussing the study results with leadingallergy specialists to define the potential clinical benefit of MPL in orallyadministered allergy vaccines and is completing an evaluation of the formulationof a commercial product in preparation for further Phase II development. What does it mean for allergy sufferers? Allergic rhinitis or hay fever affects 35.9 million people in the United Statesalone according to the AAAAI and is a large and growing problem. Worldwide over150 million people are estimated to suffer from allergic rhinitis. The development of a convenient, effective, short course, oral allergy vaccinewould have significant implications for allergy therapy and redefine the marketfor allergy products. Currently available oral allergy vaccines requireprolonged treatment periods leading to poor patient compliance and low efficacy. There is an existing substantial unmet medical need and substantial costs tosociety including US$12 billion of spending on pharmaceuticals each year. Full Details of Study 103 The purpose of Study 103 was to investigate the potential benefit of MPL whenadministered orally for the first time as part of a sublingual vaccine. Study 103 was a double-blind placebo-controlled safety study evaluatingdifferent doses of MPL and grass pollen allergen involving 4 groups of 20 grasspollen sensitive subjects (16 active plus 4 placebo per group). Subjects selfadministered the liquid sublingual vaccines daily for 8 weeks and assessmentswere made during and 2 weeks after the dosing period. Group 1 received AllergyTherapeutics' Oralvac Plus grass pollen vaccine; Group 2 received a similarvaccine incorporating a low dose of MPL and Group 3 likewise but with a higherdose of MPL. Group 4 received the higher dose of MPL but with a higher grasspollen allergen dose. Comparisons were made with the overall number of patientson placebo (n=16). The primary objective of the study was safety and tolerability. Throughout thestudy, all vaccines were well tolerated with no patients withdrawn due toadverse events and no reports of serious or severe adverse reactions. Thenature of adverse events was as expected with slightly more patients reportingtransient mild itching in the mouth during the first couple of days on activetreatment compared to placebo. There was no evidence of any adverse effectassociated with the use of MPL. The secondary objective of the study was to investigate the contribution of MPLto the activity of the vaccines as measured by clinical (nasal challenge) andimmunological (IgG, IgG1, IgG4 and IgE) parameters. The nasal challenge test involves the objective measurement of nasal airflow,together with assessment of nasal secretions and irritation and other non-nasalsymptoms, at 10, 20 and 30 minutes after allergen is sprayed into the nose. Anegative test indicates minimum reaction to the allergen challenge throughout.Groups 3 and 4 show a notably greater proportion of patients with a negativenasal challenge compared to placebo (44% vs 19%) following treatment (ITT). Afurther analysis indicates that Groups 3 and 4 (high dose MPL) show astatistically significant improvement in nasal challenge over placebo combinedwith Groups 1 and 2 (low dose MPL) (p