Verona Pharma Receives Regulatory Approval to Commence Phase 2b Clinical Trial of RPL554 for COPD Maintenance Treatment in Five Countries across Europe
Dose escalation trial will evaluate RPL554 as a maintenance treatment in approximately 400 COPD patients
LONDON, June 27, 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 regulatory approval in five European countries, comprising the United Kingdom, Germany, Romania, Bulgaria, and the Czech Republic, for a Phase 2b dose-ranging trial of RPL554 for maintenance treatment of chronic obstructive pulmonary disease (COPD). The trial is expected to commence in the third quarter of 2017, with top-line data expected 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.
This double-blind, placebo-controlled, parallel group, four-week trial will investigate the efficacy, safety, and dose-response of nebulized RPL554 for the maintenance treatment of COPD across approximately 400 people with the disease in the above named countries. The primary endpoint is evaluating improvement in lung function with RPL554 compared with placebo, as measured by FEV1, a standard measure of exhaled breath volume used to evaluate respiratory function.
"This dose escalation trial directly supports our ongoing development plans for RPL554 and we look forward to enrolling patients in these, and potentially additional countries, subject to further approvals," said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "This four-week, 400-patient study is an important step forward in evaluating the potential of RPL554 as a promising first-in-class treatment option for the 210 million people around the world who suffer from COPD on an ongoing basis."
This clinical trial 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.
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 commercialising 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.
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 the commencement of the Phase 2b clinical trial and 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, plans to enrol patients in other countries subject to approvals, and projected medical costs for COPD.
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.
For further information, please contact:
|Verona Pharma plc||Tel: +44 (0)20 3283 4200|
|Jan-Anders Karlsson, Chief Executive Officeremail@example.com|
|N+1 Singer (Nominated Adviser and UK Broker)||Tel: +44 (0)20 7496 3000|
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|ICR, Inc. (US Media and Investor Enquiries)|
|Darcie Robinson||Tel: +1 203 682 8379|
|Stephanie Carrington||Tel: +1 646 277 1282|
|FTI Consulting (UK Media and Investor Enquiries)||Tel: +44 (0)20 3727 1000|
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Source: Verona Pharma plc via GlobeNewswire