Verona Pharma Completes Enrollment in Phase 2b Clinical Trial with Nebulized Ensifentrine in moderate-to-severe COPD

17th October 2019

Results to Inform Development Plan and Dose Selection for Phase 3

LONDON, Oct. 17, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a biopharmaceutical company focused on respiratory diseases, announces that it has randomized the last patient in its Phase 2b dose-ranging study evaluating the effect of nebulized ensifentrine as an add-on to treatment with a long acting bronchodilator in patients with moderate-to-severe chronic obstructive pulmonary disease (“COPD”).

Ensifentrine has the potential to be the first novel class of bronchodilator in over 40 years, and the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The addition of nebulized ensifentrine to symptomatic COPD patients already treated with standard-of-care medicines represents a significant market opportunity.

Highlights:

  • Enrollment completed on schedule with data expected around year end 2019
  • Preparations underway for End-of-Phase 2 meeting with the U.S. FDA expected in the first half of 2020
  • Commencement of Phase 3 trials expected in 2020

“We remain on track to deliver data from this important Phase 2b clinical trial in patients with moderate-to-severe COPD around year end 2019. We expect this second Phase 2 study with nebulized ensifentrine in COPD to help inform our planned Phase 3 clinical development program, which we expect to start in 2020. Millions of COPD patients urgently need better treatments as they remain symptomatic despite maximum treatment with currently available therapies. We believe ensifentrine, with its unique mode of action and clinical profile, will have an important role in treating these patients.”

Jan-Anders Karlsson, PhD, CEO of Verona Pharma.

This four-week randomized, double-blind, placebo-controlled dose-ranging Phase 2b trial enrolled a total of 416 patients with moderate-to-severe symptomatic COPD at 46 sites in the U.S. The trial is designed to evaluate the safety and efficacy of nebulized ensifentrine as an add-on to inhaled tiotropium, a long acting anti-muscarinic (“LAMA”) commonly used to treat patients with COPD.

Patients will receive nebulized ensifentrine at four dose levels: 0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg or placebo twice daily for four weeks. The trial’s primary endpoint is improvement in lung function with ensifentrine after four weeks of treatment, as measured by peak forced expiratory volume in one second (“FEV1”), a standard measure of lung function. Key additional endpoints include other lung function measures, as well as measurements of symptoms associated with COPD and quality of life outcomes. For further information on this clinical trial, please visit ClinicalTrials.gov, NCT03937479.

Verona Pharma is also developing two additional formulations of ensifentrine, a dry powder inhaler (“DPI”) and a pressurized metered-dose inhaler (“pMDI”). In July 2019, the company reported positive data from its Phase 2 trial with the DPI formulation, which demonstrated statistically significant and clinically meaningful dose-dependent improvements in lung function in moderate-to-severe COPD. Verona Pharma is conducting a Phase 2 trial with the pMDI formulation and expects to report data from the first part of the trial in the fourth quarter of 2019, with final data expected in the first half of 2020.

About COPD
COPD is a progressive and life-threatening respiratory disease without a cure. The World Health Organization estimates that it will become the third leading cause of death worldwide by 2030. The condition damages the airways and the lungs, leading to debilitating breathlessness that has a devastating impact on performing basic daily activities such as getting out of bed, showering, eating and walking. In the United States alone, the total annual medical costs related to COPD are projected to rise to $49 billion in 2020. About 1.2 million US COPD patients on dual/triple inhaled therapy (LAMA/LABA +/- ICS) remain uncontrolled, experiencing symptoms that impair quality of life. These patients urgently need better treatments.

About Ensifentrine
Nebulized ensifentrine (RPL554) has shown significant and clinically meaningful improvements in both lung function and COPD symptoms, including breathlessness, in Verona Pharma’s prior Phase 2 clinical studies in patients with moderate-to-severe COPD. In addition, nebulized ensifentrine showed 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.