Verona Pharma has announced the initiation of the Phase 3 ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) program to study the use of nebulized ensifentrine for the treatment of moderate to severe COPD. In July 2020, the company announced that it had raised approximately $200 million for Phase 3 development of the nebulized formulation for COPD.
In January 2020, Verona announced positive results from a Phase 2b dose-ranging study of nebulized ensifentrine as an add on to tiotropium for the treatment of COPD. Several months later, the company said that it planned to move ahead with Phase 3 development after it received the FDA’s response to its Phase 2 data.
The ENHANCE program includes two 24-week randomized, double-blind, placebo-controlled studies comparing 3 mg nebulized ensifentrine twice daily, either alone or as an add on to either a LAMA or a LABA, to placebo. ENHANCE-1 will also include a 48 week safety study. ENHANCE-1 and ENHANCE-2 are each expected to enroll about 800 COPD patients.
Verona Pharma President and CEO David Zaccardelli commented, “We are excited to start our pivotal ENHANCE Phase 3 studies. If successful, the data will support the submission of a New Drug Application in the US for nebulized ensifentrine for the maintenance treatment of COPD. This is an important milestone for Verona Pharma and we look forward to addressing the urgent need for a novel therapy for the treatment of COPD.”
MDI and DPI formulations of ensifentrine are also in development for the treatment of COPD, and the company recently initiated a a study of the ensifentrine MDI in patients hospitalized with COVID-19.
Read the Verona Pharma press release.
