China-based Nuance Pharma has secured approval from the National Medical Products Administration (NMPA) to conduct both Phase I and Phase III clinical trials for ensifentrine, a dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), as a maintenance treatment for chronic obstructive pulmonary disease (COPD).
Partnership and Development
The drug is being developed in partnership with UK-based Verona Pharma plc (NASDAQ: VRNA) under a deal announced in June 2021, valued at up to USD 219 million. The agreement grants Nuance development and commercialization rights for Greater China, including mainland China, Hong Kong, Macau, and Taiwan. The deal includes a USD 25 million upfront payment and a USD 15 million equity stake in Nuance Biotech, Nuance Pharma’s parent company.
Drug Profile
Ensifentrine is an inhaled, first-in-class dual inhibitor with both bronchodilator and anti-inflammatory properties. The global Phase III ENHANCE-2 trial, assessing ensifentrine as a COPD maintenance treatment, is underway in the US, Europe, and South Korea, with Verona recently reporting positive results. The drug is also being evaluated for cystic fibrosis and asthma.-Fineline Info & Tech
