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VRP Verona Pharma Plc

55.00
0.00 (0.00%)
28 Mar 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Verona Pharma Plc LSE:VRP London Ordinary Share GB00BYW2KH80 ORD 5P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 55.00 45.00 65.00 0.00 00:00:00
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

Verona Pharma plc Verona Pharma Reports Patient Enrollment Progressing Ahead Of Schedule In Ongoing Phase 2b Clinical Trial O...

07/11/2017 7:00am

UK Regulatory


 
TIDMVRP 
 
 
   Top-line data from the study now expected in mid-2018 
 
   LONDON, Nov. 07, 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 it has enrolled more than 
200 patients in its ongoing Phase 2b study to evaluate RPL554 for the 
maintenance treatment of chronic obstructive pulmonary disease (COPD). 
 
   The four-week, double-blind, placebo-controlled, parallel group Phase 2b 
study is expected to enroll in total approximately 400 patients with 
moderate-to-severe COPD at a number of sites across Europe to 
investigate the efficacy, safety, and dose-response of nebulized RPL554 
as a maintenance treatment for COPD. RPL554 is being dosed twice-daily 
and patients are required to withhold their regular long-acting 
bronchodilator therapy for the duration of the study. The primary 
endpoint of the study is improvement in lung function, as measured by 
forced expired volume in one second (FEV(1) ), after dosing with RPL554 
or placebo. The secondary endpoints are morning trough FEV(1) , COPD 
daily symptoms, dyspnea scale, and the St. George's Respiratory 
Questionnaire (SGRQ), a COPD specific quality of life scale. 
 
   "We are pleased to be making excellent progress in this important study 
as we have exceeded the 50 percent recruitment milestone and are 
enrolling ahead of schedule," said Jan-Anders Karlsson, PhD, CEO of 
Verona Pharma. "We are on track to complete enrollment faster than our 
original timeline, and are confident of now reporting top-line data in 
mid-2018, sooner than our previous guidance of 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 
maintenance treatment of COPD patients and for the treatment of patients 
with cystic fibrosis. 
 
   In previous clinical trials, RPL554 has been observed to result in 
bronchodilatory effects when used alone or as an add-on treatment to 
other COPD bronchodilators. It has shown clinically meaningful and 
statistically significant improvements in lung function when 
administered in addition to frequently used short- and long-acting 
bronchodilators compared with such bronchodilators administered as a 
single agent. In addition, RPL554 has shown anti-inflammatory effects in 
a standard challenge study with COPD-like inflammation in human 
subjects. In these studies, RPL554 has been well tolerated. 
 
   About COPD 
 
   Chronic obstructive pulmonary disease (COPD) is a progressive and 
life-threatening respiratory disease for which there is no cure.(1)  The 
condition damages the airways and the lungs, leading to persistent 
breathlessness, impacting a person's daily life and their ability to 
perform simple activities such as walking a short flight of stairs or 
carrying a suitcase.(1)  Although COPD is thought to be underdiagnosed, 
globally, around 384 million people suffer from the disease.(1,[2]) 
This number, according to the World Health Organization (WHO), is likely 
to increase in coming years, with estimates that COPD will become the 
third leading cause of death worldwide by 2030.(1,[3])  Current COPD 
therapies focus on reducing and controlling symptoms. Yet, despite the 
wide availability of these treatments, many patients continue to suffer 
acute periods of worsening symptoms known as exacerbations. These 
exacerbations often lead to emergency department visits or hospital 
admissions, and are also associated with high mortality.(4)  In the 
United States alone, the 2010 total annual medical costs related to COPD 
were estimated to be $32 billion, and are projected to rise to $49 
billion in 2020.(5) 
 
   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 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. 
 
   For further information, please contact: 
 
 
 
 
Verona Pharma plc                              Tel: +44 (0)20 3283 4200 
Jan-Anders Karlsson, Chief Executive Officer   info@veronapharma.com 
 
Stifel Nicolaus Europe Limited                 Tel: +44 (0) 20 7710 7600 
 (Nominated Adviser and UK Broker)              SNELVeronaPharma@stifel.com 
Stewart Wallace / Jonathan Senior / Ben 
Maddison 
 
FTI Consulting (UK Media and Investor          Tel: +44 (0)20 3727 1000 
enquiries) 
Simon Conway / Natalie Garland-Collins         veronapharma@fticonsulting.com 
 
ICR, Inc. (US Media and Investor enquiries) 
James Heins                                    Tel: +1 203-682-8251 
                                               James.Heins@icrinc.com 
Stephanie Carrington                           Tel. +1 646-277-1282 
                                               Stephanie.Carrington@icrinc.com 
 
 
   ___________________ 
 
   (1)  World Health Organization. Chronic Obstructive Pulmonary Disease. 
http://www.who.int/mediacentre/factsheets/fs315/en/. Accessed September 
2017. 
 
   (2)  Adeloye D, Chua S, et al. Global and regional estimates of COPD 
prevalence: Systematic review and meta-analysis. J Glob Health 2015; 
5(2): 020415. 
 
   (3)  World Health Organization. Burden of COPD. 
http://www.who.int/respiratory/copd/burden/en/. Accessed September 2017. 
 
   (4)  COPD Foundations. Characteristics of COPD Patients Using United 
States Emergency Care or Hospitalization. 
https://journal.copdfoundation.org/jcopdf/id/1103/Characteristics-of-COPD-Patients-Using-United-States-Emergency-Care-or-Hospitalization. 
Accessed September 2017. 
 
   (5)  Center for Disease Control. Increase Expected in Medical Costs for 
COPD. https://www.cdc.gov/features/ds-copd-costs/. Accessed September 
2017. 
 
   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

November 07, 2017 02:00 ET (07:00 GMT)

Copyright (c) 2017 Dow Jones & Company, Inc.

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