Verona Pharma Doses First Patients in Phase 2b Clinical

LONDON, July 26, 2017 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM:VRP) (NASDAQ: VRNA ) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces today that the first patients have been dosed in a Phase 2b clinical trial evaluating RPL554 as a maintenance treatment for chronic obstructive pulmonary disease (“COPD”). Verona Pharma expects to report top-line data from this trial in the second half of 2018.

RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have anti-inflammatory, as well as bronchodilator properties, and is currently in development for the treatment of COPD and cystic fibrosis.

The four-week, dose-ranging trial is planned to enroll approximately 400 patients with COPD to investigate the efficacy, safety, and dose-response of nebulized RPL554 as a maintenance treatment for the disease. The primary endpoint of this double-blind, placebo-controlled, parallel group study is improvement in lung function with RPL554 compared to placebo, as measured by FEV ₁ , a standard measure of exhaled breath volume used to evaluate respiratory function.

The trial is being performed at a number of sites across Europe and is part of Verona Pharma’s global strategic services agreement with QuintilesIMS to provide core clinical trial services for RPL554 clinical development programs, as well as provide additional insights to inform development and commercial strategy. 

“Dosing our first patients in this larger four-week Phase 2b trial is an important step forward in the evaluation of nebulized RPL554 as a novel therapy for COPD patients with significant unmet medical needs,” said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. “The clinical data generated to date and the mechanism of action of RPL554 makes it a promising first-in-class treatment option. We look forward to working with patients and healthcare providers across the trial sites to gather meaningful data and insights, and expect to report top-line results from this study in the second half of 2018.”

In previous clinical trials in patients with COPD, RPL554 has been observed to result in statistically significant improvements in lung function as compared to placebo and has shown clinically meaningful and statistically significant improvements in lung function when added to two commonly used bronchodilators as compared to either bronchodilator administered as a single agent. RPL554 has also shown anti-inflammatory effects and has been well tolerated in clinical trials.

About Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disease for which there is no cure. The condition damages the airways and the lungs, leading to cough, mucus secretion and shortness of breath, impacting a person's ability to perform daily activities. According to the World Health Organization, COPD is the third leading cause of death globally, with 210 million people worldwide suffering from the disease. Current therapies to treat COPD are aimed at reducing and controlling symptoms. Despite the wide availability of these therapies, many COPD patients continue to suffer acute periods of worsening symptoms known as exacerbations. In the U.S. alone, these exacerbations are associated with approximately 1.5 million emergency department visits, 687,000 hospitalizations, and 129,000 deaths per year. The total annual medical costs related to COPD in the U.S. were estimated to be $32 billion in 2010, and are projected to rise to $49 billion in 2020.

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, RPL554, is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that acts as both a bronchodilator and an anti-inflammatory agent in a single compound. Verona Pharma is developing RPL554 for the treatment of chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF), and potentially asthma.

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 design of the Phase 2b clinical trial of RPL554, the timing of availability of top-line data for the Phase 2b clinical trial, the importance of the Phase 2b clinical trial to our development plans for RPL554, the potential of RPL554 as a promising first-in-class treatment option for COPD, and the value of the data and insights that may be gathered from the Phase 2b clinical trial.

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 RPL554, 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 RPL554, 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 RPL554, which could adversely affect our ability to develop or commercialize RPL554; potential delays in enrolling patients, which could adversely affect our research and development efforts; we may not be successful in developing RPL554 for multiple indications; our ability to obtain approval for and commercialize RPL554 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 RPL554; and lawsuits related to patents covering RPL554 and the potential for our patents to be found invalid or unenforceable. These and other important factors under the caption “Risk Factors” in our final prospectus filed with the Securities and Exchange Commission (“SEC”) on April 28, 2017 relating to our Registration Statement on Form F-1, 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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