Verona Pharma plc Verona Pharma Receives Who Approval For "Ensifentrine" As Recommended Inn For Rpl554

 
TIDMVRP 
 
 
   Assignment of the "-fentrine" stem in the INN attests to RPL554's dual 
phosphodiesterase inhibitor mechanism of action 
 
   LONDON, Jan. 09, 2019 (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 World Health 
Organization ("WHO") approved "ensifentrine" as the recommended 
International Non-proprietary Name ("INN") for the company's drug 
candidate, RPL554. 
 
   Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes 
phosphodiesterase 3 and 4 designed to have bronchodilator as well as 
anti-inflammatory properties, and is currently in development for the 
maintenance treatment of chronic obstructive pulmonary disease ("COPD"), 
cystic fibrosis ("CF") and potentially asthma. The "-fentrine" stem 
indicates recognition from the WHO that RPL554 inhibits multiple 
phosphodiesterases, rather than a single phosphodiesterase, such as 
phosphodiesterase 3 or 4 alone. 
 
   "We are pleased to receive approval from the WHO for the use of 
'ensifentrine', which to our knowledge, is the only molecule with an INN 
assignment using the '--fentrine' stem currently in clinical 
development. We believe that this designation underlines our drug 
candidate's position as a novel compound with a dual bronchodilator and 
anti-inflammatory mechanism of action," said Jan-Anders Karlsson, PhD, 
CEO of Verona Pharma. "We are very encouraged by the positive data from 
our studies evaluating ensifentrine in COPD and CF, and look forward to 
advancing this novel drug candidate into late stage development as a 
potential new treatment for patients." 
 
   "Ensifentrine is the only dual bronchodilator and anti-inflammatory drug 
candidate currently in development that I have come across in my 
research. This could be significant for patients and healthcare 
providers alike as there have been no new bronchodilator treatment 
classes over the last four decades," said Gerard Criner, MD, FACP, FACCP, 
Chair and Professor of Thoracic Medicine and Surgery, Lewis Katz School 
of Medicine at Temple University. 
 
   In Phase 2 clinical trials completed to date, ensifentrine has been 
observed to result in bronchodilator effects when used alone or as an 
add-on treatment to other COPD bronchodilators, and has also shown 
anti-inflammatory effects in a standard challenge study with COPD-like 
inflammation in human subjects. Verona Pharma is currently conducting 
two further Phase 2 clinical trials: one to evaluate a nebulized 
formulation of ensifentrine as an add-on treatment to dual LAMA/LABA 
therapy and triple LAMA/LABA/ICS therapy, and the other to evaluate a 
dry powder inhaler ("DPI") formulation of ensifentrine for the 
maintenance treatment of COPD. The company also plans to evaluate 
ensifentrine in a metered-dose inhaler ("MDI") formulation as part of a 
comprehensive clinical program intended to fully demonstrate the 
clinical utility of ensifentrine in improving the standard of care for 
COPD. These data will be used to support the planning of the 
ensifentrine Phase 3 COPD program. 
 
   About Verona Pharma plc and ensifentrine 
 
   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, ensifentrine (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 previous clinical trials, the nebulized formulation of 
ensifentrine has been observed to result in bronchodilator 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, such as 
tiotropium (Spiriva(R) ), compared with such bronchodilators 
administered as a single agent. Ensifentrine improved FEV(1) over four 
weeks in patients with moderate-to-severe COPD when compared to placebo 
and improved COPD symptoms and quality of life in a Phase 2b multicenter 
European study performed in 403 patients. In addition, ensifentrine has 
shown anti-inflammatory effects in a standard challenge study with 
COPD-like inflammation in human subjects. Ensifentrine has been well 
tolerated in these studies and has shown a favorable safety and 
tolerability profile, having been administered to more than 730 subjects 
in 12 clinical trials. Verona Pharma is developing ensifentrine for the 
treatment of COPD, 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 ensifentrine being 
the only molecule with an INN using the '--fentrine' stem currently in 
clinical development, the INN underlining ensifentrine's position as a 
novel compound with a dual mechanism of action, the advancement of 
ensifentrine into later stages of clinical development, including the 
use of data from the on-going Phase 2 studies in the planning of a Phase 
3 program in COPD, ensifentrine's treatment potential and potential 
indications, the significance of ensifentrine for patients and 
healthcare providers, plans to evaluate ensifentrine in an MDI 
formulation, and demonstrating the clinical utility of ensifentrine. 
 
   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 ensifentrine, 
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 ensifentrine, 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 ensifentrine which could adversely affect our ability to develop or 
commercialize ensifentrine; potential delays in enrolling patients, 
which could adversely affect our research and development efforts; we 
may not be successful in developing ensifentrine for multiple 
indications; our ability to obtain approval for and commercialize 
ensifentrine 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 ensifentrine; and lawsuits related to patents covering 
ensifentrine and the potential for our patents to be found invalid or 
unenforceable. These and other important factors under the caption "Risk 
Factors" in our Annual Report on Form 20-F filed with the Securities and 
Exchange Commission ("SEC") on February 27, 2018, 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 
 
FTI Consulting (UK Media and Investor enquiries)   Tel: [phone] 
Simon Conway / Natalie Garland-Collins             [e-mail] 
 
ICR, Inc. (US Media and Investor enquiries) 
Darcie Robinson                                    Tel: [phone] 
                                                    [e-mail] 
Stephanie Carrington                               Tel. [phone] 
                                                    [e-mail] 
 
 
 
 

(END) Dow Jones Newswires

January 09, 2019 08:00 ET (13:00 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.