Circassia Announces Positive Data Presented at 2018 American Thoracic Society Conference from Tudorza® Phase IV and Duaklir® Phase III Studies
May 22, 2018 |
OXFORD, UK – May 22, 2018 – Circassia Pharmaceuticals plc, 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<0.001) during the first year of treatment.
- 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 hospitalizations 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 results
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<0.001 and 167 mL vs 109 mL, p<0.05 respectively).
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.