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Nuance Pharma Completes Phase 3 Trial Recruitment of Ensifentrine for COPD in China

• Nuance Pharma has completed patient recruitment for the ENHANCE-CHINA phase 3 trial evaluating ensifentrine for COPD maintenance treatment. • The trial assesses the efficacy and safety of ensifentrine over 24 weeks in adult patients with moderate to severe COPD across 46 hospitals in China. • Ensifentrine, a first-in-class PDE3/PDE4 dual inhibitor, combines bronchodilator and anti-inflammatory effects in a single molecule. • The completion of recruitment sets the stage for results in 2025, potentially offering a new treatment option for COPD patients in China.

Nuance Pharma announced the completion of patient recruitment for the ENHANCE-CHINA (NCT05743075) study, a phase 3 clinical trial evaluating ensifentrine (Ohtuvayre™) for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The randomized, double-blind, placebo-controlled trial is being conducted across 46 hospitals in mainland China and will assess the efficacy and safety of ensifentrine over 24 weeks in adult patients with moderate to severe COPD.

Ensifentrine: A Novel Approach to COPD Treatment

Ensifentrine (Ohtuvayre™) is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3; PDE4). This innovative drug combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule, delivered directly to the lungs via a standard jet nebulizer. This delivery method eliminates the need for high inspiratory flow rates or complex hand-breath coordination, potentially improving ease of use for patients.

Regulatory Milestone and Future Prospects

In June 2024, Verona Pharma plc (Nasdaq: VRNA), Nuance Pharma's global partner, received US FDA approval for Ohtuvayre™ for the maintenance treatment of COPD in adult patients. This approval underscores the potential of ensifentrine as a valuable therapeutic option.
"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," said Mark Lotter, founder and CEO of Nuance Pharma. "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."

Trial Design and Endpoints

The ENHANCE-CHINA trial is designed to evaluate the impact of ensifentrine on lung function and COPD symptoms. The primary endpoint is likely to include changes in FEV1 (Forced Expiratory Volume in one second), a key indicator of lung function. Secondary endpoints may include assessments of COPD exacerbations, quality of life, and safety parameters.

Significance for COPD Treatment in China

COPD poses a significant health burden in China, with millions of individuals affected. The introduction of Ohtuvayre™ could represent a substantial advancement in COPD treatment, offering a novel mechanism of action and a potentially improved delivery method. The results of the ENHANCE-CHINA trial, expected in 2025, will be crucial in determining the role of ensifentrine in the management of COPD in the Chinese population.
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Reference News

[1]
Nuance Pharma completes recruitment for ENHANCE-CHINA, the phase 3 clinical trial of ...
en.prnasia.com · Sep 11, 2024

Nuance Pharma completes patient recruitment for ENHANCE-CHINA phase 3 trial of ensifentrine (Ohtuvayre™) for COPD treatm...

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