Analysis supports ensifentrine’s efficacy in COPD as monotherapy and on top of standard of care treatment in patients who remain symptomatic

Six abstracts accepted demonstrating ensifentrine’s potential across treatment settings and formulations

LONDON, May 01, 2020 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that six abstracts presenting clinically relevant findings from its clinical trials with first-in-class development candidate, ensifentrine, for the treatment of chronic obstructive pulmonary disease (“COPD”) have been accepted by the American Thoracic Society International Conference (“ATS”) 2020. The abstracts are published on the ATS website and today in the peer reviewed publication, American Journal of Respiratory and Critical Care Medicine.

The presentations include a late-breaking abstract that expands on Phase 2b efficacy and symptom data first announced by the Company on January 13, 2020 where nebulized ensifentrine added on to tiotropium demonstrated clinically and statistically significant dose-dependent improvements in lung function as well as COPD symptoms. Other abstracts include clinical data from three previous studies that demonstrate ensifentrine’s potential in additional treatment settings and with the dry powder formulation. These include further analyses of positive Phase 2b efficacy (subgroup analysis), symptom (responder analysis) and safety data with nebulized ensifentrine as a monotherapy in patients with COPD as well as an analysis of additional lung function improvement when nebulized ensifentrine was added to dual COPD therapy. In addition, one abstract analyses positive Phase 2 data with ensifentrine in a dry powder inhaler formulation dosed over 7 days in patients with COPD.

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: “Ensifentrine has demonstrated significant additional benefits to bronchodilation, symptoms and quality of life when used as an add-on therapy to tiotropium. I am especially encouraged by the significant improvements in quality of life measurements over the 4 week treatment period. This is very important for patients who remain symptomatic despite using standard COPD medications and supports the potential for ensifentrine to provide a meaningful difference in the treatment of COPD patients.”

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

Late-breaking Abstract: A4213 – Ensifentrine Provides Significant and Clinically Meaningful Bronchodilation and Quality of Life Improvement on Top of Tiotropium in Symptomatic COPD Patients in a 4-Week Dose-Ranging Study
Participant: Gary Ferguson, Principal Investigator, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, US
Session: B93 – Late Breaking Clinical Trials in Airway Diseases

Abstract: A4578 – Responder Analyses For Symptom And QoL (E-RS, TDI And SGRQ-C) Improvement With Nebulized Ensifentrine Dosed Twice Daily Over 4 Weeks
Participant: Tara Rheault, Vice President, R&D and Global Project Management, Verona Pharma
Session: C23. Assessment of Outcome Risk in Obstructive Lung Disease

Abstract: A3323 – Safety of Ensifentrine, a Dual PDE3/4 Inhibitor: Results of Reported GI and CV Events from a Four Week Randomized, Controlled Trial
Participant: Kathleen Rickard, Chief Medical Officer, Verona Pharma
Session: B41. Therapeutic Intervention, Quality Improvement and Treatment Adherence in Obstructive Lung Disease

Abstract: A4297 – Bronchodilation and Symptom Improvement with Ensifentrine, A Dual PDE3/4 Inhibitor: Sub-Group Analyses of a Four Week Randomized, Controlled Trial in Patients with COPD
Participant: Tara Rheault, Vice President, R&D and Global Project Management, Verona Pharma
Session: B103. Treatment of Obstructive Lung Disease

Abstract: A4298 – Additional Bronchodilation by Ensifentrine, A Dual PDE3/4 Inhibitor, When Combined with a LAMA/LABA in Patients with Moderate to Severe COPD
Participant: Kathleen Rickard, Chief Medical Officer, Verona Pharma
Session: B103. Treatment of Obstructive Lung Disease

Abstract: A4296 – Ensifentrine, A Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Provides Effective Bronchodilation in COPD When Administered Twice Daily Over 7 Days Via a Dry Powder Inhaler
Participant: Tara Rheault, Vice President, R&D and Global Project Management, Verona Pharma
Session: B103. Treatment of Obstructive Lung Disease

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. US sales of medicines used for chronic maintenance therapy of COPD were $9.6 billion in 2019. 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.

About Ensifentrine

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, 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 evaluating three formulations of ensifentrine for the treatment of COPD in Phase 2 clinical trials: 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

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, the development of ensifentrine, the progress and timing of clinical trials, data and meetings with the FDA, 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 activities in one compound, the potential for ensifentrine to have a significant impact on the treatment of COPD, estimates of medical costs for COPD and the number of symptomatic COPD patients, and the potential application of ensifentrine for the treatment of cystic fibrosis, asthma and other respiratory diseases.

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; and our vulnerability to natural disasters, global economic factors and other unexpected events, including health epidemics or pandemics like the novel coronavirus (COVID-19). 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 February 27, 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.

For further information, please contact:

Verona Pharma plc	Tel: +44 (0)20 3283 4200
David Zaccardelli, Chief Executive Officer	info@veronapharma.com
Victoria Stewart, Director of Communications
N+1 Singer (Nominated Adviser and UK Broker)	Tel: +44 (0)20 3283 4200
Aubrey Powell / George Tzimas / Iqra Amin (Corporate Finance)
Tom Salvesen (Corporate Broking)
Optimum Strategic Communications (European Media and Investor Enquiries)	Tel: +44 (0)203 950 9144 verona@optimumcomms.com
Mary Clark / Eva Haas / Shabnam Bashir
Argot Partners (US Investor Enquiries)	Tel: +1 212-600-1902 verona@argotpartners.com
Stephanie Marks / Kimberly Minarovich / Michael Barron

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