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Tudorza® Meets Primary Endpoints in ASCENT Study
Tudorza® Meets Primary Endpoints in ASCENT Study.
About this update from Niox Group Plc
[{"type":"text","content":"\n \nRNS Number : 2178Y Circassia Pharmaceuticals Plc 04 December 2017 \n\nCircassia Announces Tudorza® Successfully Met Both Primary Endpoints in ASCENT Phase IV Study in Chronic Obstructive Pulmonary Disease\nØ Significantly reduced COPD exacerbations\nØ Demonstrated favourable cardiovascular safety profile similar to placebo\nØ Circassia's partner AstraZeneca plans to file data for inclusion in US label\n \nOxford, UK - 4 December 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 ASCENT phase IV post-marketing study of Tudorza®* in over 3,600 patients with moderate to very severe chronic obstructive pulmonary disease (COPD) and documented cardiovascular risk factors. The study was conducted by the Company's partner AstraZeneca. Tudorza® contains the long-acting muscarinic antagonist (LAMA) aclidinium bromide administered via Pressair®** inhaler. \n \nThe ASCENT study met its primary efficacy endpoint, with Tudorza® demonstrating statistically significant reductions in the rate of moderate or severe COPD exacerbations compared with placebo. In addition, Tudorza® met its primary safety endpoint, demonstrating a favourable cardiovascular safety profile, with the time to patients experiencing a first major adverse cardiovascular event similar to placebo. Cardiovascular disease is the most common and significant comorbidity of COPD. A full evaluation of the ASCENT 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 responsibility for marketing Tudorza® in the United States, and AstraZeneca is responsible for conducting the product's clinical studies. Following the successful completion of the ASCENT study, AstraZeneca plans to file a supplemental New Drug Application (sNDA) with the United States Food and Drug Administration (FDA) to request inclusion of the trial data in Tudorza®'s label. \n \nSteve Harris, Circassia's Chief Executive, said: \"We are delighted with these positive Tudorza® clinical results, which underline the product's safety an...