Sunovion Pharmaceuticals, a biopharma focused on the development of medical solutions for respiratory, neurological, and psychiatric conditions, recently announced positive results from the Phase 3 trial program assessing SUN-101 (glycopyrrolate) for the treatment of moderate-to-very severe chronic obstructive pulmonary disease (COPD).
Massachusetts-based Sunovion said the GOLDEN-3 and GOLDEN-4 clinical studies met their primary endpoints.
The company intends to present data from both studies at upcoming medical meetings, and is planning to submit a New Drug Application (NDA) to the U.S. FDA for SUN-101 this year.
SUN-101 is a nebulized long-acting muscarinic antagonist (LAMA), delivered via the innovative eFlow nebulizer system developed by PARI Pharma GmbH. The eFlow system delivers the medication in two to three minutes, compared to a standard jet nebulizer, which takes up to 10 minutes. The combined products — SUN-101 and eFlow — have not yet been approved by the U.S. FDA for the treatment of COPD.
“We chose the closed eFlow nebulizer system to pair with SUN-101 because it represents a new type of nebulizer system which combines the attributes of both nebulizers and hand-held inhalers,” said Alistair Wheeler, head of Global Clinical Research, Respiratory Medicine and Biotherapeutics at Sunovion Pharmaceuticals, in a company press release. “This system is designed to provide COPD patients who are in need of LAMA therapy with a handheld aerosolized inhalation option.”
The GOLDEN-3 (NCT02347761) and GOLDEN-4 (NCT02347774) trials were Phase 3, 12-week, randomized, placebo-controlled, multicenter studies that aimed to assess the efficacy and safety of SUN-101/eFlow, and compare it with placebo in adults with moderate-to-very severe COPD. The trials enrolled 653 and 641 people respectively, and SUN-101/eFlow 50 mcg, SUN-101/eFlow 25 mcg, or placebo, administered twice daily.
Both GOLDEN studies achieved their primary endpoint, meaning a statistically significant change from baseline in forced expiratory volume in one second (FEV1 — a lung function measurement) at week 12 for both dose groups versus placebo.
“The results from the GOLDEN-3 and GOLDEN-4 trials represent significant progress in our mission to deliver medicines to people with COPD,” said Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, and head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “We look forward to filing an NDA and the possibility of making SUN-101/eFlow available for patients.”