By Fineline Cube 
China-based Nuance Pharma announced positive topline results from the ENHANCE-CHINA study (NCT05743075) for its nebulized Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD). The Phase III study met its primary and secondary endpoints, demonstrating significant improvements in lung function.
Ensifentrine Mechanism and Delivery
Ensifentrine is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3; PDE4), combining bronchodilator and non-steroidal anti-inflammatory effects in one molecule. It is delivered directly to the lungs through a standard jet nebulizer, eliminating the need for high inspiratory flow rates or complex hand-breath coordination.
Clinical Trial Results
The ENHANCE-CHINA study enrolled 526 subjects. Ensifentrine demonstrated a 28% reduction in the rate of moderate/severe COPD exacerbations over 24 weeks compared to placebo. Clinically meaningful improvements in dyspnea, as measured by the Transition Dyspnea Index (TDI), were observed at all weeks (6, 12, and 24), with a statistically significant improvement of 0.8 units compared to placebo at week 24. Quality of Life (QoL), as measured by St George’s Respiratory Questionnaire (SGRQ) Total Score, improved significantly by -2.9 units compared to placebo at week 24. Additionally, ensifentrine was well-tolerated, with treatment-related adverse event incidence similar to placebo.-Fineline Info & Tech