Verona Pharma Initiates Phase 2 Clinical Trial Evaluating Nebulized RPL554

Verona Pharma (AIM:VRP) (Nasdaq:VRNA) a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces the initiation of a Phase 2 clinical trial evaluating the effect of nebulized RPL554 as an add-on to treatment with dual long-acting anti-muscarinic / long-acting beta2-agonist drugs (“LAMA/LABA”), which are commonly used in the maintenance treatment of patients with moderate to severe chronic obstructive pulmonary disease (“COPD”). The first patients have been enrolled and dosed in the study, and top line data are expected in the first quarter of 2019.

As quoted in the press release:

The randomized, double-blind, three-way crossover trial, being conducted at sites in the U.S. and in the U.K., will enroll approximately 75 patients with COPD 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.

“We have already demonstrated that RPL554 is an effective add-on treatment to short- and long-acting bronchodilators in COPD patients. This Phase 2 trial will now examine the effect of RPL554 as an add-on to LAMA/LABA therapy, and in some patients to triple therapy, as many of these COPD patients continue to experience breathing difficulties and daily symptoms that impair their quality of life despite concomitant treatment with two bronchodilators. We believe the bronchodilator and anti-inflammatory properties of RPL554 may be particularly useful in this large group of patients with high, unmet medical need. This phase 2 trial is intended to provide important data to inform the design of pivotal Phase 3 studies with RPL554, expected to commence later next year,” said Jan-Anders Karlsson, PhD, CEO of Verona Pharma.

Click here to read the full press release.