Verona Pharma plc Verona Pharma Receives Regulatory Approval To Commence Phase 2b Clinical Trial Of Rpl554 For Copd Maintenan...

 
TIDMVRP TIDMVRP 
 
 
   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. 
 
   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 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: [phone] 
Jan-Anders Karlsson, Chief Executive Officer   [e-mail] 
 
N+1 Singer (Nominated Adviser and UK Broker)   Tel: [phone] 
Aubrey Powell / James White 
 
ICR, Inc. (US Media and Investor Enquiries) 
Darcie Robinson                                Tel: [phone] 
                                               [e-mail] 
Stephanie Carrington                           Tel: [phone] 
                                               [e-mail] 
 
FTI Consulting (UK Media and Investor          Tel: [phone] 
Enquiries) 
Simon Conway / Stephanie Cuthbert /            [e-mail] 
 Natalie Garland-Collins 
 
 
 
   This announcement is distributed by Nasdaq Corporate Solutions on behalf 
of Nasdaq Corporate Solutions clients. 
 
   The issuer of this announcement warrants that they are solely 
responsible for the content, accuracy and originality of the information 
contained therein. 
 
   Source: Verona Pharma plc via Globenewswire 
 
 
  http://www.veronapharma.com/ 
 

(END) Dow Jones Newswires

June 27, 2017 02:00 ET (06:00 GMT)

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