According to Nuance Pharma, the Chinese Center for Drug Evaluation has approved the company’s IND, allowing for a Phase 3 trial of nebulized ensifentrine, a PDE3/PDE4 inhibitor for the treatment of COPD, in China. The IND also grants approval for a Phase 1 PK study in healthy volunteers that the company plans to conduct in China. Nuance acquired the Chinese rights to ensifentrine from Verona Pharma in June 2021 in a deal worth up to $219 million.
Verona Pharma recently announced positive results from its ENHANCE-2 Phase 3 trial of nebulized ensifentrine, which demonstrated significant improvements in lung function and reduction of exacerbations in COPD patients. Verona’s ENHANCE-1 Phase 3 trial is ongoing, with results expected by the end of this year.
Nuance Pharma Chief Medical Officer Haijin Meng said, “We are thrilled to introduce this first-in-class molecule to China and give our Chinese investigators and subjects the opportunity to participate in the global clinical development of this novel molecule and to evaluate how to apply it to Chinese COPD clinical setting properly.”
Nuance Pharma CEO Mark G. Lotter commented, “This is a significant milestone for Nuance Pharma, and we are confident that we will achieve solid and inspiring progress for the development of ensifentrine in China. COPD is the fifth leading cause of death in China with a reported prevalence of 8.2% in the population aged 40 years and above. We strongly believe ensifentrine will be an effective COPD therapy to address the unmet medical needs in mainland China.”
Verona Pharma President and CEO David Zaccardelli said, “We are pleased our development partner, Nuance Pharma, has received IND approval to begin pivotal studies in COPD with ensifentrine in mainland China. This is an important milestone and, based on our recent positive Phase 3 results from our ENHANCE-2 trial in COPD, we remain confident about the potential of ensifentrine to address the urgent global need for a novel treatment for COPD.”
Read the Nuance Pharma press release.
