Nuance Pharma has initiated the ENHANCE – China Phase 3 study of nebulized ensifentrine in mainland China, the company said. Nuance obtained the rights to develop and market ensifentrine in China, Macau, Taiwan, and Hong Kong from Verona Pharma in 2021 and in August 2022, the company said that the Chinese Center for Drug Evaluation had approved its IND for Phase 1 and Phase 3 trials of the inhalation solution. According to Nuance, the Phase 1 trial was initiated last month.
In August 2022, Verona announced that the Phase 3 ENHANCE-2 trial of ensifentrine had met its primary endpoint as well as several secondary endpoints. Data from Verona’s other Phase 3 trial, ENHANCE-1, were announced in December 2022; that trial also met its primary endpoint. COPD patients in both trials experienced significant improvements in lung function and reductions in exacerbations.
Nuance Pharma CEO Mark G. Lotter said, “It gives me great pleasure to announce the first dosing of ENHANCE-China Phase 3 trial. This represents a crucial milestone for our collaboration with Verona Pharma and is indicative of a strong opening to the China clinical development program. Ensifentrine combines bronchodilator and non-steroidal anti-inflammatory properties in one compound, differentiating it from existing drug classes used to treat COPD. We are looking forward to introducing this novel drug in Greater China to address unmet needs in the COPD market.”
Verona President and CEO David Zaccardelli commented, “We are pleased our development partner, Nuance Pharma, has begun pivotal studies in COPD with ensifentrine in mainland China. This is a significant milestone and, based on our recent highly positive Phase 3 results in COPD, we are excited about the potential of ensifentrine to address the urgent global need for a novel treatment for COPD.”
Read the Nuance Pharma press release.
