Pivotal Phase 3 Trials Demonstrate SUN-101/eFlow is Safe, Effective, Analyses Show
Pooled data from three Phase 3 clinical trials shows that the investigative SUN-101/eFlow product is well-tolerated and improves lung function in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD).
Data from the GOLDEN-3, GOLDEN-4, and GOLDEN-5 clinical studies were subject of poster presentations during the American College of Chest Physicians (CHEST) Annual Meeting 2017 in Toronto, Canada.
SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator that has been developed by Sunovion Pharmaceuticals to be delivered via the PARI Pharma GmbH’s proprietary investigational nebulized eFlow closed system.
This investigative therapy is being developed to promote all the therapeutic benefits of LAMAs, the first-line standard of care for COPD, with the advantage of the nebulizer eFlow system that delivers the drug directly to the lungs.
LAMAs work as bronchodilators, helping the lung-surrounding muscles to relax and preventing airway constriction symptoms, such as wheezing, coughing, chest tightness, and shortness of breath.
“Because COPD symptoms vary for each person and often become more severe over time, it is important to have therapeutic options to manage individuals over their disease continuum,” Thomas H. Goodin, PhD, senior director of clinical development at Sunovion, said in a press release.
“Sunovion has a long-standing commitment to improving the lives of people living with COPD, building on our heritage in nebulized treatment and advancing innovative new therapies that address unmet needs.” Goodin added.
The safety and effetiveness of SUN-101/eFlow is being evaluated in the pivotal Phase 3 GOLDEN program that comprises the GOLDEN-3 (NCT02347761) and GOLDEN-4 (NCT02347774) 12-week, placebo-controlled studies, and the GOLDEN-5 (NCT02276222) a 48-week trial. The studies included a total of 2,381 patients diagnosed with COPD.
Analysis of pooled data from GOLDEN-3 and GOLDEN-4 clinical trials showed that twice daily administration of 25 mcg and 50 mcg SUN-101/eFlow resulted in clinically meaningful improvements in lung function, compared to placebo, by the end of the 12-week treatment period.
The therapeutic benefit of SUN-101/eFlow was found to be independent of the age of the patients, or the severity of their condition in the beginning of the study. This finding suggests that SUN-101/eFlow can provide clinical benefit to high-risk subgroups of patients with COPD.
Additional evaluation of the effects of treatment with twice daily SUN-101/eFlow for up to 48 weeks confirmed the 12-week data, demonstrating that the investigative therapy can provide long-lasting clinical lung function improvements to patients with moderate-to-very-severe COPD.
The positive effect of the treatments surpassed those obtained with twice daily 18 mcg of Spiriva (tiotropium bromide), and was sustained independently of the background therapy the patients were receiving.
SUN-101/eFlow was found to be safe and overall well-tolerated, even by patients with high-risk cardiovascular factors.
These findings were presented at CHEST annual meeting in four studies:
- “Peak Inspiratory Flow Rate Baseline Measurements in Placebo-Controlled Phase 3 Studies of a Novel, Nebulized Glycopyrrolate Formulation,”
- “Exploratory Analysis of Exacerbation Incidence by Patient Subgroup in Three Phase 3 Trials of Nebulized Glycopyrrolate/eFlow CS,”
- “Cardiovascular Safety and Efficacy of Nebulized Glycopyrrolate/eFlow CS in Phase 3 Trials of Patients With Moderate to Very Severe COPD,” and
- “The Effect of Concurrent Bronchodilator Therapy on the Efficacy and Safety of a Novel, Nebulized Glycopyrrolate in Phase 3 Studies in Subjects With Moderate to Very Severe COPD.”
A new drug application for SUN-101/eFlow system as long-term treatment of airflow obstruction in COPD is under review by the U.S. Food and Drug Administration (FDA). A final decision is expected by Dec. 15, 2017. If approved, SUN-101/eFlow is going to be the first nebulizer system to deliver LAMAs approved for the treatment of COPD in the U.S.
“If approved, SUN-101/eFlow will offer an important new nebulized treatment for many different people living with COPD currently in need of new options,” said Gary Ferguson, MD, director of the Pulmonary Research Institute of Southeast Michigan and principal investigator of the GOLDEN-5 clinical trial.