Verona Pharma said that it plans to initiate the second phase of a two-part Phase 2 trial of its RPL554 ensifentrine DPI in COPD patients after the first part of the study demonstrated that the DPI produced significant improvement in FEV1. The company announced initiation of the study in December 2018.
The Phase 2 study enrolled 37 moderate-to-severe COPD patients and compared 150 µg, 500 µg, 1500 µg, 3000 µg, or 6000 µg doses of ensifentrine to placebo. According to the company, doses of 1500 µg and up resulted in dose-dependent increases in peak FEV1 of up to 333mL. A dose response was also demonstrated for average FEV1 over 4 hours and 12 hours, and the formulation was well tolerated.
Verona Pharma CEO Jan-Anders Karlsson said, “The large bronchodilator response, 12-hour duration of action and good tolerability observed with the DPI ensifentrine formulation in the first portion of this study are very encouraging and we look forward to proceeding with the second part to evaluate treatment over a one-week period. Positive data from this and future studies with inhaler formulations could dramatically expand the clinical utility and commercial opportunity for ensifentrine not only in the treatment of COPD, but potentially in other respiratory diseases such as asthma.”
In the second part of the trial, patients will receive twice daily doses (150 µg, 500 µg, 1500 µg, or 3000 µg) of ensifentrine or placebo for seven days, repeated 5 times so that each patient will get each dose and placebo. The company said that it anticipates reporting results from both parts of the study in the second half of this year.
Verona is also continuing development of nebulized RPL554, which has been in Phase 2b trials, and said that it has a Phase 2 clinical trial of an RPL554 MDI for the treatment of COPD planned for the second quarter of 2019. The company is also developing inhaled ensifentrine for cystic fibrosis and asthma.
Read the Verona Pharma press release.
