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Analysis confirms continued symptom benefits improving over time, supporting anti-inflammatory effects of ensifentrine in addition to bronchodilation

LONDON, May 20, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (VRP.L) (VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, today presents clinically relevant findings from its chronic obstructive pulmonary disease (“COPD”) clinical trial program with lead product candidate, ensifentrine (RPL554), at the American Thoracic Society International Conference (“ATS”) in Dallas, TX. Positive results from the 4-week, 400-patient Phase 2b study were initially reported in March 2018.

The expanded analysis is supportive of the differentiated, dual mechanism of action of ensifentrine, as both a bronchodilator and an anti-inflammatory agent in a single compound. It provides further evidence of the potential for ensifentrine to provide significant symptom benefits to patients.

“These encouraging data suggest that ensifentrine’s dual mode of action combining anti-inflammatory and bronchodilator effects will lead to additional symptom benefits in COPD patients,” said Dave Singh, M.D., Professor of Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit, University of Manchester, and presenter of the poster at ATS. “Importantly, ensifentrine was highly effective in improving symptoms independently of the magnitude of the bronchodilator response, suggesting that the activity of the PDE3/4 inhibitor is different to that of available bronchodilators when used alone or in combination. The anti-inflammatory activity may be responsible for this effect as it cannot be explained by bronchodilation alone.”

Details of the expanded analysis are available on Verona Pharma’s website here.
Details of the abstract were provided in the announcement dated May 2, 2019 and are available at the American Thoracic Society website at
https://www.atsjournals.org/doi/abs/...bstracts.A3846

Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been shown in several previous clinical studies to act both as a bronchodilator and an anti-inflammatory agent in a single compound. It is currently being evaluated in a further Phase 2b clinical trial as an add-on to standard therapy for the maintenance treatment of COPD, with data anticipated around year-end and expected to inform dose selection for Phase 3 trials. Verona Pharma expects to hold an end-of-Phase 2 meeting with the FDA in the first half of 2020 and plans to enter Phase 3 trials in 2020.

In addition to advancing the nebulized formulation, Verona Pharma has also developed dry powder inhaler (“DPI”) and pressurized metered dose inhaler (“pMDI”) formulations 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.

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 2010 total annual medical costs related to COPD were estimated to be $32 billion and are projected to rise to $49 billion in 2020. About 800,000 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 Verona Pharma plc
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. Verona Pharma’s product candidate, ensifentrine (RPL554), is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been shown to act as both a bronchodilator and an anti-inflammatory agent in a single compound. Ensifentrine is currently in Phase 2b clinical development for the maintenance treatment of COPD and is planned to enter Phase 3 trials for this indication in 2020. Verona Pharma may also develop ensifentrine for the treatment of cystic fibrosis and asthma.

In 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.