Nuance Pharma and its partner Verona Pharma plc have received clearance from the Center of Drug Evaluation for the investigational new drug (IND) application for ensifentrine.
The application means both phase 1 and phase 2 studies looking at the drug for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in mainland China.
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 including mainland China, Hong Kong, Macau and Taiwan.
In return, Verona Pharma received an upfront payment of $25 million in cash and an equity interest valued at $15 million in Nuance Biotech, the parent company of Nuance Pharma. In addition, Verona Pharma is eligible to receive future milestone payments as well as double-digit royalties as a percentage of net sales in Greater China.
David Zaccardelli, chief executive officer at Verona Pharma, 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.”