Pharma Focus Asia

Nuance Pharma Announces Clearance of IND Application for Ensifentrine Pivotal Clinical Trials for COPD in China

Friday, August 19, 2022

Nuance Pharma announces the Center for Drug Evaluation ("CDE") has approved its Investigational New Drug ("IND") application supporting its pivotal clinical trial of Ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease ("COPD") in mainland China.

Ensifentrine is a first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3" and "PDE4") combining bronchodilator and anti-inflammatory activities in one compound. This activity has the potential to alleviate respiratory symptoms such as breathlessness and cough, as well as providing anti-inflammatory benefits for those with COPD.

On August 9th, 2022, Verona Pharma announced its ENHANCE-2 Phase III trial evaluating nebulized Ensifentrine for the maintenance treatment of COPD met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function, and significantly reduced the rate and risk of COPD exacerbations. Verona Pharma expects to report top-line results from its ongoing ENHANCE-1 Phase III trial around the end of the 2022 and, if similarly positive, plans to submit a New Drug Application to the US Food and Drug Administration for Ensifentrine in 1H2023.  

Under this Ensifentrine Chinese IND approval, conduction of both Phase I and Phase III studies in China are granted. According to Dr. Haijin Meng, CMO of Nuance Pharma, the company is planning to conduct a Phase I study to evaluate the detailed pharmacokinetic characteristics of Ensifentrine in healthy Chinese volunteers. Meanwhile, the pivotal Phase III study is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ensifentrine over 24 weeks in patients with moderate to severe COPD. "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," she said.

In 2021, Nuance Pharma entered into an agreement with Verona Pharma with a potential value of up to $219 million, granting Nuance Pharma exclusive rights to develop and commercialize Ensifentrine in Greater China (mainland China, Hong Kong, Macau and Taiwan). In return, Verona Pharma received an upfront payment of USD 25 million in cash and an equity interest valued at USD 15 million. Meanwhile, Verona Pharma is eligible to receive future milestone payments as well as double-digit royalties as a percentage of net sales in Greater China.

"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," commented Mark G. Lotter, CEO and Co-Founder of Nuance Pharma. "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."

"We are pleased our development partner, Nuance Pharma, has received IND approval to begin pivotal studies in COPD with Ensifentrine in mainland China," said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. "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."

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