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Primary Endpoints Met in AMPLIFY Phase III Study
Primary Endpoints Met in AMPLIFY Phase III Study.
About this update from Niox Group Plc
[{"type":"text","content":"\n \nRNS Number : 0457Q Circassia Pharmaceuticals Plc 07 September 2017 \n\nCircassia Announces Duaklir® Successfully Met Primary Endpoints in AMPLIFY Phase III Study in Chronic Obstructive Pulmonary Disease\nØ NDA submission planned H1 2018 by partner AstraZeneca\nØ Filing supported by positive results from ACHIEVE dose-ranging study\nØ Circassia has exclusive commercialisation rights to Duaklir® in the United States\n \nOxford, UK - 7 September 2017: Circassia Pharmaceuticals plc (\"Circassia\" or \"the Company\"; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces positive top-line results from the AMPLIFY phase III study of Duaklir®* in chronic obstructive pulmonary disease (COPD), which was conducted by the Company's partner AstraZeneca. Duaklir® is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and long-acting beta-agonist (LABA) formoterol fumarate, administered via the Pressair®** inhaler. \n \nThe AMPLIFY study met its co-primary efficacy endpoints with Duaklir® demonstrating statistically significant and clinically meaningfully improvements in lung function, measured by forced expiratory volume in one second (FEV1), compared with the combination's individual component monotherapies (aclidinium and formoterol). Aclidinium monotherapy (Tudorza®*** Pressair®) also achieved its primary bronchodilation endpoint demonstrating non-inferiority to tiotropium (Spiriva® Handihaler®). Additionally, a sub-study of 24-hour bronchodilation demonstrated statistically significant greater night-time bronchodilation for twice-daily Duaklir® and Tudorza® compared to once-daily Spiriva®. The safety profiles of Duaklir® and its individual components were consistent with previous studies. A full evaluation of the AMPLIFY data is ongoing and the results will be submitted for presentation at a forthcoming medical meeting. \n \nNext steps\nUnder the April 2017 collaboration established between Circassia and AstraZeneca, Circassia has exclusive commercialisation rights to Duaklir® in the United States and AstraZeneca is responsible for conducting the product's development. Circassia also has responsibility for marketing Tudorza® in the United States. \n \nFollowing the completion of the ...