Verona Pharma to Present Clinical Trial Data of Ensifentrine for COPD Maintenance Treatment at American Thoracic Society 2019 International Conference

LONDON, May 02, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc VRP VRNA ("Verona Pharma"), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that it will present data 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, from May 17-22, 2019. The abstract reports post-hoc analyses of the four-week placebo controlled dose-ranging study, with patients sub-grouped by baseline reversibility of lung function measured pre- and post-albuterol administration.

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. It is currently in Phase 2b clinical trials for the maintenance treatment of COPD and is planned to enter Phase 3 trials in 2020.

Details of the Company's poster presentation are listed below and the abstract is now available to the public online at the American Thoracic Society website (http://conference.thoracic.org/).

Thematic Poster Session (Abstract 3846, Poster 596): RPL554 (Dual PDE3/4 Enzyme Inhibitor): Baseline Airway Reversibility Impacts Immediate Bronchodilation, in Contrast To Progressive Symptom Improvement

Session Title: COPD: Mechanism and Treatment (B64)

Date and Time: Monday, May 20, 2019; 9:15 AM - 4:15 PM CDT*

Location: Kay Bailey Hutchison Convention Center Dallas, Area D (Hall F, Level 2)

Dave Singh, M.D., Professor of Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit, University of Manchester, will be available at the poster session from 11:15 AM – 1:00 PM CDT.

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.

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the value of trial results presented at ATS, ensifentrine as a new complementary treatment for patients with COPD, projected annual medical costs related to COPD, the future clinical development and positioning of ensifentrine, and the treatment potential for ensifentrine.

These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our research and development efforts; we may not be successful in developing  ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, and third-party service providers; material differences between our "top-line" data and final data; our reliance on third parties, including clinical investigators, manufacturers and suppliers, and the risks related to these parties' ability to successfully develop and commercialize ensifentrine; and lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable. These and other important factors under the caption "Risk Factors" in our Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on March 19, 2019, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

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