Nuance Pharma Completes Enrollment for Phase III COPD Trial of Ohtuvayre in China

Nuance Pharma, a China-based pharmaceutical company, has announced the completion of patient enrollment for the Phase III ENHANCE-CHINA study (NCT05743075) for its drug Ohtuvayre (ensifentrine). This Phase III trial is a randomized, double-blind, placebo-controlled investigation assessing the efficacy and safety of Ohtuvayre over a 24-week period in adult patients diagnosed with moderate to severe chronic obstructive pulmonary disease (COPD). The study is being conducted across 46 hospitals in mainland China.

Ohtuvayre, known generically as ensifentrine, is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3; PDE4). This innovative drug offers a dual therapeutic approach by combining bronchodilator and non-steroidal anti-inflammatory effects within a single molecule. It is administered directly to the lungs via a standard jet nebulizer, eliminating the need for high inspiratory flow rates or complex hand-breath coordination.

In 2021, Nuance Pharma secured an exclusive agreement with Verona Pharma for the development and commercialization rights of Ohtuvayre in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan. The drug recently received marketing approval in the US in June this year as a maintenance treatment for COPD. – Flcube.com

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