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Findings from mEEC dose range finding study G204
Findings from mEEC dose range finding study G204.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 2800C Allergy Therapeutics PLC 27 June 2016 \n\n \n \n \n \n \n27 June 2016\n \nAllergy Therapeutics plc\n(\"Allergy Therapeutics\" or the \"Company\")\n \nAllergy Therapeutics announces findings from mEEC dose range finding study G204\n \n~ Further dose range finding required and US plans progress with goal of being first to market ~\n \n~ Group's European sales accelerate at 19% growth rate ~\n \nAllergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces findings from its exploratory Phase II dose-ranging study (G204) for the US GrassMATAMPL clinical development program and informs that the results did not determine a recommended dose for the Phase III trial. A further dose range finding study will be implemented prior to proceeding into the planned pivotal Phase III study. GrassMATAMPL is an ultra-short course subcutaneous allergen specific immunotherapy (\"SCIT\") administered prior to the grass pollen season.\n \nBased on the successful dose response data identified in the Phase II G203 study for the same US GrassMATAMPL programme, the G204 trial was designed to explore higher dose regimens using the novel technology of the mEEC (mobile environmental exposure chamber) and optimise the recommended dose before starting the pivotal Phase III trial (G306) to be performed in the US. \n \nIn contrast to the G203 study, the dose range finding data with the mEEC did not allow the Company to recommend an optimised dose regime to take into Phase III studies for the US. Consequently, Allergy Therapeutics will undertake a further dose-ranging study employing the same successful European dose-finding trial design with a fixed Conjunctival Provocation Test (CPT) which provided robust results for the optimisation of the Company's marketed subcutaneous birch pollen product, Pollinex® Quattro Birch (PQBirch).\n \nThe next dose range finding study is planned to start in 2017. Allergy Therapeutics will await the outcome of an End of Phase II meeting with the FDA, scheduled later in 2016, before progressing into Phase III.\n \nCommenting on the announcement, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: \"Defining the optimal dose is...