Nuance Pharma has announced that the Phase 3 ENHANCE-CHINA study of nebulized ensifentrine in patients with COPD has met its primary endpoint. The company obtained the rights to ensifentrine, a PDE3/PDE4 inhibitor, in China, Macau, Taiwan, and Hong Kong from Verona Pharma in 2021 and announced the initiation of the ENHANCE-CHINA trial in April 2023.
Nuance says that Macau’s Pharmaceutical Administration Bureau approved Ohtuvayre nebulized ensifentrine for the treatment of COPD in February 2025. In the US, Verona’s NDA for Ohtuvayre inhaled ensifentrine for the treatment of COPD was approved by the FDA in June 2024.
According to Nuance, the ENHANCE-CHINA study randomized 526 patients and demonstrated a 110 mL change in baseline in average FEV1 AUC 0-12hr at week 12. The company said that several secondary endpoints related to lung function were also met and that quality of life and exacerbation rate reduction endpoints were consistent with ENHANCE 1 and ENHANCE 2.
Nuance Pharma CEO Mark Lotter commented, “We are very pleased by the successful outcome of our Phase 3 ENHANCE-CHINA study, bringing us another step closer to providing a much needed novel therapy for COPD patients in China. These promising results demonstrate ensifentrine’s strength as a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD, as an advance to existing treatment options. We plan to submit a New Drug Application to the China NMPA in the second half of 2025. We would like to thank all the patients and investigators for their participation in the ENHANCE-CHINA program.”
Chief Operating Officer Charlie Chen said, “The totality of ENHANCE data including improvements in lung function, symptoms, quality of life measure and reduction in exacerbations, coupled with favorable safety profile, support our belief that ensifentrine will change the treatment paradigm for COPD. Following our ongoing early access programs in Hainan BoAo and Greater Bay Area, as well as regulatory approval in Macau, we look forward to bringing this medicine to patients in Greater China.”
Verona President and CEO David Zaccardelli commented, “We look forward to Nuance Pharma’s continued progress and having Ohtuvayre available for the millions of symptomatic patients needing additional treatment.”
Read the Nuance Pharma press release.
