Verona Pharma Announces Publication of Key Phase 2b COPD Data in Respiratory Research
Paper demonstrates ensifentrine’s potential in improving lung function and quality of life symptoms
LONDON, February 14, 2020 – Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces publication of Phase 2b clinical trial results for ensifentrine as a maintenance treatment for chronic obstructive pulmonary disease (“COPD”) in the leading peer reviewed journal, Respiratory Research. The study met its primary endpoint demonstrating that ensifentrine produced clinically and statistically significant improvements in lung function at all doses. Also, clinically relevant secondary endpoints were met including significant progressive improvements in COPD symptoms.
The paper, entitled “A dose-ranging study of the inhaled dual phosphodiesterase 3 and 4 inhibitor ensifentrine in COPD,” was published on-line here. Results from the 4-week 400-patient study were first reported in March 2018 and further positive analysis was presented in May 2019 at the American Thoracic Society International Conference.
Lead development candidate ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been shown to act both as an anti-inflammatory and bronchodilator agent in a single compound. In January 2020, Verona Pharma reported positive top-line results from a second 4-week 400-patient Phase 2b study with nebulized ensifentrine added on to inhaled tiotropium (Spiriva® Respimat®) therapy in symptomatic COPD patients.
Dave Singh, M.D., Professor of Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit, University of Manchester, and Lead Investigator in the study commented: “These encouraging data published in Respiratory Research, combined with ensifentrine’s unique mode of action, support its potential as a novel therapy to meet the high unmet medical need in COPD. The improvements in patients’ symptoms, including breathlessness, are particularly noteworthy.”
David Zaccardelli, Pharm. D., President and CEO of Verona Pharma, said: “The compelling data from our two successful Phase 2b studies in COPD, one in patients with no background therapy and the second in symptomatic patients already on maintenance therapy, are further evidence of ensifentrine’s promising therapeutic potential. We look forward to discussing these results, along with positive data from previous clinical studies, in an End-of-Phase 2 meeting with the FDA, anticipated for 2Q 2020. We expect this meeting to provide key guidance with respect to the design of our Phase 3 program.”
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, long-acting beta-agonist (LABA)/long-acting muscarinic antagonist (LAMA) +/- inhaled corticosteroid (ICS) remain uncontrolled, experiencing symptoms that impair quality of life. These patients urgently need better treatments.
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 1300 people to date.
About Verona Pharma
Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. Verona Pharma is currently in Phase 2 development with three formulations of ensifentrine for the treatment of COPD: nebulized, dry powder inhaler, and pressurized metered-dose inhaler. Ensifentrine also has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.
- Verona Pharma
- Verona Pharma