Nuance Pharma's New COPD Drug Achieves Successful Phase III Study, Will File for Market Approval
Nuance Pharma has made significant progress in the development of drugs for chronic obstructive pulmonary disease (COPD). Its newly introduced inhaled drug, ensifentrine, showed excellent performance in its Phase III clinical trials in China, meeting all its pre-specified goals.
On May 16, Nuance Pharma announced that the Phase III ENHANCE-CHINA study of Ensifentrine, an inhaled new drug it has in-licensed for the treatment of chronic obstructive pulmonary disease (COPD), has successfully met both primary and secondary endpoints. Based on these positive results, Nuance Pharma plans to submit a new drug application (NDA) for this drug to the National Medical Products Administration (NMPA) in the second half of 2025.
It is reported that Ensifentrine, developed by Verona Pharma, is a differentiated phosphodiesterase 3/4 (PDE3/4) inhibitor with dual effects of bronchodilation and anti-inflammation. It can also activate the cystic fibrosis transmembrane conductance regulator (CFTR), reducing mucus viscosity and improving mucociliary clearance function. In June 2021, Nuance Pharma entered into a cooperation with Verona Pharma, securing the development and commercialization rights of this drug in the Greater China region with a total transaction value of up to USD 219 million (including an upfront payment of USD 25 million).
The ENHANCE-CHINA study was a randomized, double-blind, placebo-controlled clinical trial, which enrolled a total of 526 COPD patients receiving background therapy (in combination with long-acting muscarinic antagonist LAMA or long-acting beta-agonist LABA) to evaluate the efficacy and safety of Ensifentrine (3mg, twice daily). The results showed that, after placebo adjustment, the area under the curve (AUC 0-12h) of mean forced expiratory volume in 1 second (FEV1) within 12 hours after administration at Week 12 in the Ensifentrine group increased by 110 mL compared with the baseline (p<0.0001). Moreover, statistically and clinically significant improvements were observed in key subgroups such as age, smoking status, and disease severity. In terms of secondary endpoints, the peak FEV1 in this group increased by 174 mL (p<0.0001), the evening trough FEV1 increased by 65 mL (p=0.0038), and the incidence and risk of moderate-to-severe COPD exacerbations were reduced by 28% and 25%, respectively. Meanwhile, the drug demonstrated good safety and tolerability.