4 Dec 2017 07:00
Circassia Announces Tudorza® Successfully Met Both Primary Endpoints in ASCENT Phase IV Study in Chronic Obstructive Pulmonary Disease
Ø Significantly reduced COPD exacerbations
Ø Demonstrated favourable cardiovascular safety profile similar to placebo
Ø Circassia's partner AstraZeneca plans to file data for inclusion in US label
Oxford, 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.
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, 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.
Next steps
Under 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.
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."
Steve Lewington, Global Medicine Leader, Respiratory, AstraZeneca said: "The ASCENT data demonstrate that Tudorza®, when added to background therapy, reduces exacerbation rates in patients with cardiovascular disease or risk factors and adds to the established efficacy and safety profile of aclidinium bromide. Based on these results, AstraZeneca plans to submit an sNDA for an expanded label for Tudorza® in the US."
About ASCENT
ASCENT was a double-blind, randomised, placebo-controlled, phase IV study, which enrolled over 3,600 patients with moderate to very severe COPD in the United States and Canada. The 36-month study evaluated the effect of Tudorza® (aclidinium bromide 400µg twice daily via Pressair® inhaler) on long-term cardiovascular safety and COPD exacerbations. The study had two primary outcome measures:
· Time to first Major Adverse Cardiovascular Event (MACE).
· Rate of moderate or severe COPD exacerbations per patient per year during the first year of treatment.
The study also had a number of secondary endpoints, including the rate of hospitalisations due to COPD exacerbations and the time to first MACE or other serious cardiovascular event of interest.
About Circassia
Circassia is a world-class specialty pharmaceutical business focused on respiratory disease. Circassia sells its novel, market-leading NIOX® asthma management products directly to specialists in the United States, United Kingdom and Germany, and in a wide range of other countries through its network of partners. The Company recently established a collaboration with AstraZeneca in the US in which it promotes the chronic obstructive pulmonary disease (COPD) treatment Tudorza®, and has the US commercial rights to late-stage COPD product Duaklir®.
Circassia's development pipeline includes a range of respiratory medicines. The Company's lead asthma treatment targets substitution of GSK's Flixotide® pMDI and was approved in the UK. Circassia is also developing a direct substitute for Seretide® pMDI, and its pipeline includes a number of inhaled medicines for COPD, including single and combination dose products. For more information on Circassia please visit www.circassia.com.
Contacts
Circassia
Steve Harris, Chief Executive Officer Tel: +44 (0) 1865 405 560
Julien Cotta, Chief Financial Officer
Rob Budge, Corporate Communications
JP Morgan Cazenove
James Mitford / James Deal Tel: +44 (0) 20 7742 4000
Numis Securities
Clare Terlouw / Freddie Barnfield Tel: +44 (0) 20 7260 1000
FTI Consulting
Ben Atwell / Simon Conway / Mo Noonan Tel: +44 (0) 20 3727 1000
Forward-looking statements
This press release contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Circassia. The use of terms such as "may", "will", "should", "expect", "anticipate", "project", "estimate", "intend", "continue", "target" or "believe" and similar expressions (or the negatives thereof) are generally intended to identify forward-looking statements. These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors that could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Nothing contained in this press release should be construed as a profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. Circassia undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.
*Aclidinium is marketed under a number of brand names around the world, including Tudorza®, Eklira® and Bretaris®
**Outside of the US the Pressair® inhaler is marketed as Genuair®
Tudorza®, Pressair® and Genuair® are registered trademarks of AstraZeneca