Verona Pharma Completes Enrollment in Phase 2 Clinical Trial

Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces that is has enrolled the last patient in its Phase 2 clinical trial evaluating the effect of nebulized RPL554 as an add-on to dual therapy using long-acting anti-muscarinic / long-acting beta2-agonists and triple therapy (LAMA/LABA with an inhaled corticosteroid) in the maintenance treatment of patients with moderate to severe chronic obstructive pulmonary disease.

As quoted in the press release:

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.

Click here to read the full press release.