The phase 3 trial involved over 800 candidates to assess ensifentrine when administered as a maintenance therapy to patients diagnosed with COPD.
Verona Pharma has announced the completion of patient enrolment–with over 800 subjects randomised in the ENHANCE-2 trial–evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
The phase 3 ENHANCE programme consists of two double-blind, placebo-controlled studies, evaluating nebulised ensifentrine for the maintenance treatment of COPD. The 48-week subset of the ENHANCE-1 trial completed enrolment of approximately 400 subjects in December 2021, while enrolment in the 24-week subset of ENHANCE-1 is expected to complete in the second quarter of 2022.
The primary endpoint of the study is improvement in lung function, as measured by forced expiratory volume in one second, over 12 hours with ensifentrine after 12 weeks of treatment.
COPD is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. Symptoms include breathing difficulty, cough, mucus production and wheezing. The disease is primarily caused by long-term exposure to irritating gases, such as cigarette smoke.
Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory properties in one compound. In previous studies into COPD, ensifentrine has demonstrated clinically meaningful improvements in lung function, symptoms, and quality of life as a monotherapy, or added onto a maintenance bronchodilator.
“Completing enrollment in phase 3 ENHANCE-2 trial with more than 800 subjects is an important accomplishment for Verona Pharma,” said David Zaccardelli, Pharm D, president and CEO. “We are pleased to achieve our recruitment targets during the ongoing global pandemic.”
He added: “We expect to report top-line data from ENHANCE-2 in the third quarter of 2022 and from ENHANCE-1 around the end of 2022. We look forward to reporting these results and working with the regulatory authorities to address the urgent need for a novel treatment for COPD.”