Verona Pharma plc Verona Pharma Provides Clinical Development Update

 
TIDMVRP 
 
 
   Accelerates top-line data readouts from ongoing clinical trials with 
RPL554 in COPD and CF 
 
   LONDON, Feb. 13, 2018 (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 updated projections, bringing 
forward the timing for top-line data readouts from its ongoing clinical 
trials in chronic obstructive pulmonary disease (COPD) and cystic 
fibrosis (CF). 
 
 
   -- Phase 2b clinical trial of nebulized RPL554 for COPD Maintenance 
      Treatment: The Company anticipates reporting top-line data from its Phase 
      2b trial early in the second quarter of 2018 (previously mid-2018). The 
      four-week, double-blind, placebo-controlled, parallel group Phase 2b 
      study enrolled approximately 400 patients with moderate-to-severe COPD at 
      a number of sites across Europe and is investigating the efficacy, safety, 
      and dose-response of nebulized RPL554 as a maintenance treatment for 
      COPD. 
 
   -- Phase 2a pharmacokinetic (PK) and pharmacodynamic (PD) clinical trial of 
      RPL554 for CF: The Company anticipates reporting top-line data from its 
      Phase 2a trial in late first quarter of 2018 (previously first half of 
      2018). The double-blind, placebo-controlled, cross-over Phase 2a study is 
      evaluating the PK and PD profile and tolerability of single nebulized 
      dose of RPL554 in 10 patients with CF, as well as the effect on lung 
      function in such patients. 
 
 
   "We are pleased to be making excellent progress in these important 
studies," said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "We have 
completed the clinical phase of both studies ahead of schedule and now 
look forward to reporting top-line data sooner than our previous 
guidance." 
 
   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 
maintenance treatment of COPD patients and for the treatment of patients 
with CF. In pre-clinical studies, RPL554 has been observed to stimulate 
the CF transmembrane conductance regulator, a protein whose mutation 
results in dysfunctional ion channels in epithelial cells, leading to 
CF. Based on available data, RPL554 has the potential to enhance 
mucociliary clearance (reduce phlegm in the airways), reduce airway 
obstruction and inhibit inflammation. 
 
   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. In 
clinical trials, treatment with 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 administered in addition 
to frequently used short- and long-acting bronchodilators as compared to 
such bronchodilators administered as a single agent. Verona Pharma is 
developing RPL554 for the treatment of chronic obstructive pulmonary 
disease (COPD), 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 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; delays in analyzing our top-line data; 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] 
 
Stifel Nicolaus Europe Limited (Nominated Adviser  Tel: [phone] 
 and UK Broker) 
Stewart Wallace / Jonathan Senior / Ben Maddison   [e-mail] 
 
FTI Consulting (UK Media and Investor enquiries)   Tel: [phone] 
Simon Conway / Natalie Garland-Collins             [e-mail] 
                                                   m 
 
ICR, Inc. (US Media and Investor enquiries) 
James Heins                                        Tel: [phone] 
                                                   [e-mail] 
Stephanie Carrington                               Tel. [phone] 
                                                   Stephanie.Carrington@icrinc.c 
                                                   om 
 
 
 
   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

February 13, 2018 07:35 ET (12:35 GMT)

Copyright (c) 2018 Dow Jones & Company, Inc.