Verona Pharma plc (VRNA) Reports Publication of Phase 2b Dose-Ranging COPD Data

Verona Pharma plc (NASDAQ: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces publication of efficacy and safety results from a previously reported Phase 2b clinical trial with nebulized ensifentrine added on to maintenance bronchodilator therapy in symptomatic chronic obstructive pulmonary disease (“COPD”) patients. The study results were published in the leading peer reviewed journal, International Journal of Chronic Obstructive Pulmonary Disease.

The publication reports on results from the 4-week 416-patient study, first reported by Verona Pharma on January 13, 2020, where nebulized ensifentrine added on to maintenance tiotropium (Spiriva® Respimat®), a long-acting muscarinic antagonist (“LAMA”) bronchodilator, met the primary endpoint demonstrating clinically and statistically significant dose-dependent improvements in lung function at all doses. In addition, clinically relevant secondary endpoints were met including statistically significant and clinically meaningful improvements in quality of life compared to placebo added on to tiotropium over 4 weeks of treatment. Ensifentrine demonstrated a safety profile similar to placebo.

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

The new publication is entitled "A dose-ranging study of the novel inhaled dual PDE 3 and 4 inhibitor ensifentrine in patients with COPD receiving maintenance tiotropium therapy” and is available here. Further information about this study can be found at www.clinicaltrials.gov, NCT03937479.

Gary T. Ferguson, MD, Director of the Pulmonary Research Institute of Southeast Michigan and Principal Investigator in the Phase 2b study that evaluated ensifentrine added on to tiotropium commented: “These data in symptomatic COPD patients on maintenance bronchodilator therapy, combined with ensifentrine’s unique mode of action, support its potential as a novel COPD therapy. The improvements in patient quality of life and lung function when added to tiotropium highlight the potential of this novel mechanism of action.”

About Ensifentrine

Ensifentrine (RPL554) is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”). This dual inhibition enables it to combine both bronchodilator and anti-inflammatory effects in one compound. Ensifentrine also activates the Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”), which is beneficial in reducing mucous viscosity and improving mucociliary clearance. Ensifentrine’s mechanism of action has the potential to alleviate respiratory symptoms such as breathlessness and cough and work against inflammation associated with COPD or inflammation triggered by viruses.

Ensifentrine has demonstrated significant and clinically meaningful improvements in both lung function and symptoms, including breathlessness, in Verona Pharma’s Phase 2 clinical studies in patients with moderate to severe Chronic Obstructive Pulmonary Disease (“COPD”). In addition, nebulized ensifentrine showed further improved lung function and reduced lung volumes in COPD 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 1,300 subjects to date.

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