Circassia Announces Positive Data Presented at 2018 American Thoracic Society Conference from Tudorza Phase IV and Duaklir Phase III Studies
Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the presentation of positive clinical data from the Tudorza® Pressair® phase IV ASCENT study and Duaklir® Pressair® phase III AMPLIFY study at the American Thoracic Society (ATS) 2018 International Conference currently being held in San Diego, CA.
Steve Harris, Circassia’s CEO, said: “With both the ASCENT and AMPLIFY studies meeting their primary endpoints, the positive data presented at the American Thoracic Society conference are highly supportive for Tudorza® and Duaklir®. As a result, we look forward to regulatory filings in the coming weeks seeking US approval for Duaklir® and an extension to Tudorza®’s US prescribing information to include the ASCENT data.”
ASCENT phase IV results1
ASCENT evaluated the long-term effect of the long-acting muscarinic antagonist (LAMA) Tudorza® (aclidinium 400µg twice-daily) on cardiovascular safety and chronic obstructive pulmonary disease (COPD) exacerbations. The study was conducted in approximately 3,600 patients with moderate to very severe COPD and cardiovascular disease and / or risk factors. ASCENT was unique in that 48% of patients enrolled had at least one documented previous cardiovascular event while 96% of patients included had at least two atherothrombotic risk factors. ASCENT met its primary endpoints, demonstrating that Tudorza® is effective at reducing exacerbations with no increase in cardiovascular events in this at-risk population. The ATS conference oral presentation included a number of outcome measures:
- Primary endpoint: Tudorza® reduced the rate of moderate to severe COPD exacerbations by 22% vs placebo (p
- Primary endpoint: the time to a first major adverse cardiovascular event was similar for Tudorza® and placebo (hazard ratio 0.89; p=0.464).
- Secondary endpoint: Tudorza® reduced hospitalisations due to COPD exacerbations by 35% vs placebo (p=0.006) in the first year of treatment.
Cardiovascular disease is the most common and significant comorbidity of COPD, with approximately 30% of COPD patients dying from cardiovascular conditions. Submission of a supplemental New Drug Application (sNDA) for Tudorza® is anticipated in the coming weeks to request inclusion of the ASCENT data in the treatment’s US prescribing information. If successful Tudorza® will be the only LAMA marketed in the United States with COPD exacerbation reduction data and data demonstrating safety in patients with cardiovascular disease / risk factors in its label.
AMPLIFY phase III results2,3
AMPLIFY evaluated the efficacy of Duaklir® (aclidinium 400µg / formoterol 12µg twice-daily) compared with the product’s individual components. The study, which was conducted in more than 1,500 COPD patients over 24 weeks, met its co-primary efficacy endpoints. The ATS conference presentation included both co-primary endpoints and data from a sub-study of 24-hour bronchodilation that compared twice-daily Duaklir® with the once-daily LAMA, tiotropium (Spiriva® Handihaler®):
- Primary endpoint: Duaklir® significantly increased forced expiratory volume in one second (FEV1) from baseline one hour post dose compared with aclidinium monotherapy (253 mL vs 169 mL, p<0.0001).
- Primary endpoint: Duaklir® significantly increased FEV1 from baseline prior to morning dose (trough) compared with formoterol monotherapy (80 mL vs 25 mL, p<0.001).
- Sub-study: Duaklir® significantly improved night-time and 24-hour bronchodilation (area under the curve FEV1) compared with Spiriva® (150 mL vs 60 mL, p
Submission of a New Drug Application (NDA) seeking marketing approval for Duaklir® in the United States is anticipated in the coming weeks. The NDA will include data from the AMPLIFY study, results from two previous Duaklir® phase III studies, ACLIFORM and AUGMENT, and exacerbation data from the ASCENT trial.
About Tudorza® and Duaklir®
In April 2017, Circassia and AstraZeneca established a collaboration for the commercialisation of Tudorza® and Duaklir® in the United States. Under the companies’ agreement, Circassia has responsibility for marketing Tudorza®, and AstraZeneca is responsible for completing the product’s clinical studies and regulatory filings. Circassia also has exclusive US commercialisation rights to Duaklir®, and AstraZeneca is responsible for conducting the product’s development and regulatory filing.
About Pressair®
Pressair® is an easy-to-use, multi-dose, breath-activated inhaler with a unique patient feedback mechanism that is approved in the US for delivering Tudorza® (aclidinium bromide) and is being used for the development of Duaklir® in the United States. Outside the US the Pressair® inhaler is marketed as Genuair®.
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. In 2017, the Company established a commercial collaboration with AstraZeneca in the United States in which it promotes the chronic obstructive pulmonary disease (COPD) treatment Tudorza®, and has the commercial rights to pre-NDA COPD product Duaklir®.