The company completes its enrolment in phase 3 trial evaluating ensifentrine for treatment of COPD
Verona has announced that it has completed patient enrolment – with more than 800 subjects involved – for its randomised ENHANCE-1 trial.
The study will evaluate ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD). It is a critical step for the phase 3 ENHANCE trial with top-line data expected by the end of the year and further data from ENHANCE-2 in the third quarter of 2022.
Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in a single compound. In prior clinical studies into COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator.
“We are pleased to complete enrolment in the phase 3 ENHANCE programme with more than 1,600 across the two trials, ENHANCE-1 and ENHANCE-2,” explained David Zaccardelli, president and CEO at Verona. “Attaining our recruitment targets across multiple international sites during the ongoing pandemic is a significant achievement and we would like to thank the patients and healthcare professionals who helped us reach this important milestone.”
“As stated in our first quarter results, the top-line data from both ENHANCE trials will include the primary endpoint, improvement in lung function, as well as key secondary endpoints including measurements of COPD symptoms and health-related quality of life, including ER-S and SGRQ endpoints. We look forward to reporting these results and working with the regulatory authorities to address the urgent need for a novel treatment for COPD,” he added.
