Verona Pharma plc Verona Pharma Provides Clinical Development Update
13 February 2018 - 11:35PM
UK Regulatory
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: +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 SNELVeronaPharma@stifel.com
FTI Consulting (UK Media and Investor enquiries) Tel: +44 (0)20 3727 1000
Simon Conway / Natalie Garland-Collins veronapharma@fticonsulting.co
m
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.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)
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