Verona Pharma plc Verona Pharma Receives Who Approval For "Ensifentrine" As Recommended Inn For Rpl554
10 January 2019 - 12:00AM
UK Regulatory
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: +44 (0)20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer info@veronapharma.com
Stifel Nicolaus Europe Limited (Nominated Adviser Tel: +44 (0) 20 7710 7600
and UK Broker)
Stewart Wallace / Jonathan Senior / Ben Maddison
FTI Consulting (UK Media and Investor enquiries) Tel: +44 (0)20 3727 1000
Simon Conway / Natalie Garland-Collins veronapharma@fticonsulting.com
ICR, Inc. (US Media and Investor enquiries)
Darcie Robinson Tel: +1 203-919-7905
Darcie.Robinson@icrinc.com
Stephanie Carrington Tel. +1 646-277-1282
Stephanie.Carrington@icrinc.com
(END) Dow Jones Newswires
January 09, 2019 08:00 ET (13:00 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Verona Pharma (LSE:VRP)
Historical Stock Chart
From Apr 2024 to May 2024
Verona Pharma (LSE:VRP)
Historical Stock Chart
From May 2023 to May 2024