Circassia Pharmaceuticals plc, a specialty pharmaceutical company focused on respiratory disease, today announced 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.
The 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. 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.
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.
Steve Harris, Circassia’s Chief Executive, said:
“We are delighted with these positive Tudorza® clinical results, which underline the product’s safety and efficacy, particularly in this important group of at-risk patients. We are highly encouraged with the progress we are making in our US commercial collaboration with AstraZeneca, and look forward to our partner filing for an extension to Tudorza®’s label in the coming months.”