Nuance Pharma announced it has completed the recruitment of patients for the ENHANCE-CHINA (NCT05743075) study, after planned number of patients have been successfully enrolled. The ENHANCE-CHINA study is a phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of ensifentrine (Ohtuvayre™) over 24 weeks in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD). The ENHANCE-CHINA trial is being carried out in 46 hospitals in mainland China.

The investigational study drug, Ensifentrine (Ohtuvayre™) is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 ("PDE3; PDE4") that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule, delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.

In June 2024, Nuance Pharma's global partner Verona Pharma plc (Nasdaq: VRNA), announced the US Food and Drug Administration ("FDA") approved Ohtuvayre™ for the maintenance treatment of COPD in adult patients.

Mark Lotter, founder and CEO of Nuance Pharma, said: "We are pleased to announce that the pivotal phase 3 trial recruitment is completed, as this means that the results and outcome will be soon available in 2025. We are excited about the possibility of offering the new treatment for the COPD patients group in China, following the successful approval by US FDA earlier this year.

The introduction of Ohtuvayre™ will represent a material milestone in offering Chinese patients a new option in the treatment of COPD. The company appreciates the efforts of the leading PI Professor Zhong Nanshan and all the sites for their contribution in completion of the study and in bringing the drug one step closer to patients in China."

"We are pleased with Nuance Pharma's progress and completion of enrollment in ENHANCE-CHINA. We look forward to the study results in 2025 and continued progress to bring Ohtuvayre™ to the millions of COPD patients needing additional treatment." said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma.

In 2021, Nuance Pharma entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize Ohtuvayre™ in Greater China (mainland China, Hong Kong, Macau and Taiwan).