Verona Pharma has initiated a Phase 2 trial of the MDI formulation of RPL554 ensifentrine in COPD patients, the company said. Verona recently announced the initiation of a Phase 2b study of nebulized ensifentrine and interim results from a Phase 2 study of the DPI formulation for COPD.
The Phase 2 study of the MDI formulation is expected to enroll 36 patients with moderate-to-severe COPD and will evaluate PK profiles for 5 doses of ensifentrine or placebo in the first part of the trial. Data from that portion of the trial are expected in the second half of 2019.
The second portion of the trial will compare 4 doses of ensifentrine and placebo over a 7-day treatment period, with a primary endpoint related to bronchodilation as measured by FEV1. Data from the second part of the trial are anticipated in the first quarter of 2020.
Verona Pharma CEO Jan-Anders Karlsson commened, “We are excited to expand the ensifentrine portfolio with the MDI formulation for the treatment of patients with COPD. DPI and MDI inhaler formulations have the potential to expand dramatically the clinical utility and commercial opportunity of ensifentrine in the treatment of COPD. We plan to seek a strategic partner to develop and commercialize inhalers of ensifentrine to maximize the significant potential value from this opportunity.”
Read the Verona Pharma press release.
