Of Personal Interest 07/05/2019

Verona Pharma Initiates Additional Phase 2b Clinical Trial with Nebulized Ensifentrine to Inform Dose Selection for Phase 3 Trials

LONDON, May 07, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces the initiation of a Phase 2b dose-ranging study evaluating nebulized ensifentrine (RPL554) added on to a long acting bronchodilator in patients with moderate-to-severe chronic obstructive pulmonary disease (“COPD”). The Company anticipates reporting data around year end and commencing Phase 3 clinical trials for this indication in 2020.

Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been shown to act both as a bronchodilator and anti-inflammatory agent in a single compound.

Jan-Anders Karlsson, PhD, CEO of Verona Pharma, said: “In addition to further evaluating the potential of nebulized ensifentrine as a first-in-class therapy in symptomatic COPD patients already receiving a long-acting bronchodilator, this study is an important step towards optimizing the clinical profile of ensifentrine for the planned End-of-Phase 2 meeting with the FDA in the first half of 2020. The study is also expected to further inform the Phase 3 clinical development program for ensifentrine in terms of dose selection, patient population, background therapy and clinical endpoints.”

The four-week, randomized, double-blind, dose-ranging Phase 2b trial plans to enroll about 400 patients with moderate-to-severe COPD to evaluate the safety and efficacy of nebulized ensifentrine when added on to inhaled tiotropium, a long-acting anti-muscarinic (“LAMA”) commonly used to treat COPD. Patients will receive twice-a-day dosing for 28 days of nebulized ensifentrine at four dosage levels: 0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg. The trial is being performed at approximately 50 sites in the US.

The primary endpoint of the trial is improvement in lung function with ensifentrine after 4 weeks of treatment, as measured by peak forced expiratory volume in one second (“FEV₁”), a standard measure of lung function. FEV₁ will be measured from 0 to 3 hours after dosing.  Key additional endpoints include measurements of respiratory symptoms and quality of life measures via different patient-reported outcome tools.

In prior Phase 2 clinical studies in patients with moderate to severe COPD, ensifentrine has shown significant and clinically meaningful improvements in both lung function and COPD symptoms, including breathlessness. In addition, ensifentrine has further improved lung function and reduced lung volumes in patients taking standard short- and long-acting bronchodilator therapy, including maximum bronchodilator treatment with dual/triple therapy. Ensifentrine has been well tolerated in clinical trials involving more than 800 people to date.

In addition to advancing the nebulized formulation of ensifentrine through Phase 2b clinical development, Verona Pharma has also developed a dry powder inhaler (“DPI”) and a pressurised metered dose inhaler (“pMDI”) formulation of ensifentrine. In an ongoing Phase 2 clinical trial, the DPI formulation demonstrated dose-dependent, significant bronchodilation following a single dose, and is currently being evaluated over one week of twice-daily treatment, with top-line data expected in the third quarter this year. The pMDI formulation is planned to enter clinical evaluation in a Phase 2 study in COPD patients later this quarter.