Nuance Pharma completes recruitment for ENHANCE-CHINA, the phase 3 clinical trial of ensifentrine for the maintenance treatment of COPD

SHANGHAI, Sept. 11, 2024 /PRNewswire/ — Nuance Pharma today 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).

About Ohtuvayre™ (ensifentrine)

Ohtuvayre™ is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona Pharma evaluated nebulized Ohtuvayre™ in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ohtuvayre™ met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. Ohtuvayre™ has potential applications for development in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases.

About Nuance pharma

Nuance Pharma is an innovation focused biopharmaceutical company, with both late-stage clinical pipeline and commercial stage asset portfolio. Focusing on specialty care, Nuance has established a differentiated combination of commercialized assets and innovative pipeline across respiratory, pain management, emergency care and iron deficiency anemia. With the mission to address critical unmet medical needs in Asia Pacific, Nuance deploys the Dual Wheel model that develops a global leading innovative pipeline, while maintaining a self-sustainable commercial operation in both China and Asia as a region. For more information, please visit www.nuancepharma.com. 

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs, including COPD, non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com. 

Forward-Looking Statements

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.