Verona Pharma says that the FDA’s comments in response to the data from a Phase 2 study of the company’s RPL554 nebulized ensifentrine for the treatment of COPD support moving ahead with a Phase 3 clinical program. The Phase 3 program, called ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy), is planned for later this year.
In January 2020, Verona announced that a Phase 2b dose-ranging study of nebulized ensifentrine as an add on to tiotropium for the treatment of COPD met its primary endpoint at all doses tested. The company is also developing MDI and DPI formulations of ensifentrine.
The ENHANCE-1 and ENHANCE-2 studies are each expected to enroll 800 patients with moderate-to-severe COPD and will assess nebulized ensifentrine as a monotherapy or as an add-on to either a LAMA or a LABA. Patients will receive either twice daily 3 mg doses of ensifentrine via nebulizer or a nebulized placebo. ENHANCE-1 will also include a longer-term safety component.
Verona President and CEO David Zaccardelli said, “We are very pleased with the FDA’s response to our End-of-Phase 2 briefing package. Subject to securing additional funding, we look forward to starting our pivotal ENHANCE program later in 2020. We continue to be very encouraged by the Phase 2 results that have demonstrated ensifentrine’s effects on lung function, COPD symptoms and quality of life as well as its favorable safety profile. We look forward to building on this positive data to support the potential submission of a NDA for ensifentrine for the maintenance treatment of COPD.”
Read the Verona Pharma press release.
