A total of 79 patients with COPD have enrolled at sites in the U.S. and in the UK in this three way crossover study. It is anticipated that it will take several weeks to complete dosing. Following data analysis, top line data is expected to be available in January 2019.
This randomized, double-blind, three-way crossover trial is designed to investigate the efficacy and safety of nebulized RPL554 as an add-on to an inhaled LAMA/LABA, tiotropium/olodaterol (Stiolto Respimat), compared to placebo.
Those patients already receiving inhaled corticosteroid (“ICS”) anti-inflammatory therapy will continue a stable dose of ICS throughout the study, thus providing additional data on “triple therapy” use.
Following a 7- to 14-day washout period in advance of dosing and between study arms, patients will receive three days of treatment with each of two dose strengths (1.5 mg or 6.0 mg) of nebulized RPL554 or placebo twice daily.
The primary endpoint of this trial is improvement in lung function with RPL554 vs placebo (as add-on to tiotropium/olodaterol), as measured by peak forced expired volume in one second (FEV1), a standard measure of exhaled breath volume to evaluate respiratory function.
Verona Pharma CEO Jan-Anders Karlsson said: “We are delighted that enrollment in this Phase 2 study has been completed ahead of schedule and now expect to report top line data in January following completion of dosing and data analysis.
“We have already demonstrated that RPL554, when administered as an add-on to a single bronchodilator, produces a large and sustained improvement in lung function.
“This study is expected to further inform the positioning of RPL554 as an add-on to dual bronchodilator therapy (with some patients also on inhaled corticosteroid as background treatment) for the treatment of more severe COPD patients, who continue to experience disease progression and worsening of symptoms despite being treated with currently available COPD therapies.”
RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have bronchodilator as well as anti-inflammatory properties, and is currently in development for the maintenance treatment of COPD and for the treatment of cystic fibrosis (“CF”).
Source: Company Press Release