Verona Pharma to Present Expanded Analysis of Phase 2b COPD Data with Ensifentrine at the American Thoracic Society 2021 International Conference

LONDON and RALEIGH, N.C., May 04, 2021 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces three abstracts highlighting new analyses from Phase 2b clinical trials with nebulized ensifentrine in chronic obstructive pulmonary disease (“COPD”) have been accepted by the American Thoracic Society International Conference (“ATS”) 2021. The abstracts are published on the ATS website and in the peer reviewed publication, American Journal of Respiratory and Critical Care Medicine.

The abstracts include a new subgroup analysis evaluating the effect of ensifentrine by COPD severity from the 4-week Phase 2b study, first reported by Verona Pharma on January 13, 2020, with nebulized ensifentrine as a maintenance treatment for COPD. Nebulized ensifentrine added on to maintenance tiotropium (Spiriva^® Respimat^®), a long-acting muscarinic antagonist (“LAMA”) bronchodilator, demonstrated clinically and statistically significant dose-dependent improvements in lung function at all doses. In addition, ensifentrine showed significant and progressive improvements in quality of life.

The subgroup analysis demonstrated that ensifentrine showed similar improvement in lung function and quality of life in both severe and moderate COPD subgroups. Improvements in both subgroups were clinically meaningful after 4 weeks of treatment. In addition, health-related quality of life as measured by St. George’s Respiratory Questionnaire: COPD (“SGRQ-C”) improved in all patients regardless of COPD severity.

In a further safety subgroup analysis from the Phase 2b trial with nebulized ensifentrine added on to maintenance tiotropium, ensifentrine also demonstrated a gastrointestinal and cardiovascular safety profile similar to placebo.

In addition to the analysis by COPD severity, Verona Pharma will highlight consolidated safety data with nebulized ensifentrine in COPD from two 4-week Phase 2b trials, ensifentrine added on to maintenance tiotropium and a monotherapy study first reported on March 26, 2018. Ensifentrine demonstrated a cardiovascular safety profile similar to placebo with no evidence of any meaningful effect on vital signs, cardiac repolarization or other ECG parameters.

Details of Verona Pharma’s three abstracts are listed below with links to the ATS website.

Abstract: A2254 – Effect of Ensifentrine on Lung Function and Health-Related Quality of Life (QoL) by COPD Severity: Analysis from a Phase 2b Dose Ranging Study
Participant: Tara Rheault, Vice President of Research and Development
Session: TP40 – COPD Clinical Trials and Therapies

Abstract: A2255 – Safety of Dual PDE3/4 Inhibitor Ensifentrine Added to Tiotropium: Gastrointestinal and Cardiovascular Adverse Events from a Four-Week Randomized, Controlled Trial
Participant: Kathleen Rickard, Chief Medical Officer, Verona Pharma
Session: TP40 – COPD Clinical Trials and Therapies

Abstract: A2256 – Cardiovascular Safety Profile of Ensifentrine in Patients with COPD: Results from Two Four-Week, Dose-Ranging, Randomized, Placebo-Controlled Trials
Participant: Kathleen Rickard, Chief Medical Officer, Verona Pharma
Session: TP40 – COPD Clinical Trials and Therapies

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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.

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. The Company is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Two additional formulations of ensifentrine are in Phase 2 development for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

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 development of ensifentrine and the progress and timing of clinical trials and data, the goals and design of clinical trials, the potential for ensifentrine to be a first-in-class phosphodiesterase 3 and 4 inhibitor and to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory effects in one compound, and the potential of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of 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 and the completion of our clinical trials; 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; our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, 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; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors and other unexpected events, including health epidemics or pandemics like the COVID-19 pandemic, which has and may continue to adversely impact our business. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, 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.