Verona Pharma
plc
("Verona Pharma" or the
"Company")
Verona Pharma receives second
Venture and Innovation Award from the Cystic Fibrosis
Trust
Supports first clinical study in
patients to explore potential for RPL554 as a novel treatment
for cystic fibrosis
New data from
pre-clinical studies to be presented at Annual North
American Cystic Fibrosis Conference, 26-28
October 2016
26 October 2016, Cardiff – Verona
Pharma plc (AIM: VRP.L), a clinical-stage biopharmaceutical company
focused on developing and commercializing innovative therapeutics
for the treatment of respiratory diseases, announces that it has
received a second Venture and Innovation Award from the UK Cystic
Fibrosis Trust. The award will be used to help fund a Phase 2a
clinical study to investigate the potential of the Company’s drug
candidate, RPL554, as a novel treatment for cystic fibrosis
(CF).
The study is expected to start recruiting patients with CF
during the first half of 2017. The primary objective of the study
will be to determine the pharmacokinetic and pharmacodynamics
profile and assess the tolerability and safety of RPL554 in
patients with this disease.
The first Venture and Innovation Award the Company received from
the UK Cystic Fibrosis Trust was granted in November 2014 and was used to help fund
exploratory pre-clinical studies, which delivered encouraging data
presented last year at the North American Cystic Fibrosis
Conference and published in the American Journal of Physiology that
has shown the potential of RPL554 as a treatment of CF.
New pre-clinical data of RPL554 in CF will be available from
26 October 2016 and presented during
two poster sessions on 27 and 28 October
2016 at the Annual North American Cystic Fibrosis Conference
in Orlando, Florida.
CF is an orphan disease that afflicts approximately 70,000
people worldwide. The disease is caused by mutations in the gene
for the protein cystic fibrosis transmembrane conductance regulator
(CFTR). CF affects several organs in the body but pulmonary disease
is the primary cause of mortality. Current therapies are directed
at the impaired mucociliary clearance, the chronic lung infections
and the chronic inflammation of the lungs, but with limited
efficacy. Recently, drugs targeting the mutant CFTR function have
become available. While these latter therapies are effective in
small sub-sets of patients, most patients are still without
adequate therapy for this life-shortening, chronic progressive
disease.
RPL554, a first-in-class, inhaled, dual PDE3/PDE4 inhibitor, is
currently in Phase 2 clinical development as a nebulized treatment
for Chronic Obstructive Pulmonary Disease (COPD). In clinical
trials, RPL554 has been observed to be an effective bronchodilator
and to have anti-inflammatory properties in vitro as well as
in a standard inhaled lipopolysaccharide challenge study in healthy
volunteers. In these studies, the drug candidate has been well
tolerated. Pre-clinical data to date has suggested that RPL554 is
also a stimulator of the CFTR, which is dysfunctional in cells of
cystic fibrosis patients. Based on these observed favorable
properties, the Company believes RPL554 may improve mucociliary
clearance (reduce phlegm in the airways), reduce symptoms of
chronic inflammation and ease breathing.
Commenting on the award, Verona Pharma’s CEO, Jan-Anders Karlsson, said:
“We are delighted to have received a second Venture and
Innovation Award from the Cystic Fibrosis Trust, which will
enable us to accelerate the clinical development of RPL554 for the
treatment of cystic fibrosis, an orphan disease where there is very
high unmet medical need. The award recognises RPL554’s potential to
be a novel and important treatment for this debilitating condition
and we look forward to progressing the drug candidate through
clinical development.”
Ed Owen, outgoing Chief Executive
of the Cystic Fibrosis Trust, said: “We are delighted to
continue to support the development of this compound and explore
its potential to be an effective and complementary new treatment
for cystic fibrosis, which remains an area of significant unmet
medical need.
A vital part of our fight for a Life Unlimited is to
accelerate the development of potential new therapies for people
with cystic fibrosis. Building innovative collaborations with
companies like Verona ensures that promising drug candidates are
developed for use in cystic fibrosis and are given the best chance
to get to those who need them as quickly as possible."
The title, timing and location of the abstract presentations at
the Annual North American Cystic Fibrosis Conference are as
follows:
Abstract Number |
40 |
Authors: |
M.Turner, K.H. Abbott-Banner, S.H
Randell, J.W Hanrahan |
Title: |
PHOSPHODIESTERASE 8 IS A NOVEL
REGULATOR OF CFTR IN HUMAN BRONCHIAL EPITHELIA |
Day/Date: |
October 26-28, 2016 |
Location: |
Hall C |
Time: |
Thursday, October 27: 11:15 a.m. –
1:45 p.m.
Friday, October 28: 4:00 p.m. – 6:00 p.m. |
Session Type: |
Poster |
This announcement contains price sensitive information.
-Ends-
For further information please
contact:
Verona Pharma plc |
Tel: +44 (0)20 3283 4200 |
Jan-Anders Karlsson, Chief Executive
Officer |
|
|
|
N+1 Singer |
Tel: +44 (0)20 7496 3000 |
Aubrey Powell / Jen Boorer |
|
|
|
FTI Consulting |
Tel: +44 (0)20 3727 1000 |
Simon Conway /
Stephanie Cuthbert /
Natalie Garland-Collins |
|
Notes to Editors
About Verona Pharma plc and RPL554
Verona Pharma plc is a clinical-stage biopharmaceutical company
focused on developing and commercializing innovative therapeutics
for the treatment of respiratory diseases with significant unmet
medical needs, such as chronic obstructive pulmonary disease
(COPD), cystic fibrosis (CF) and asthma.
Verona Pharma's drug candidate, RPL554, is a first-in-class,
inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4,
or PDE3 and PDE4, that acts as both a bronchodilator and an
anti-inflammatory agent in a single molecule. The Company has
successfully completed eight Phase 1 and 2a clinical trials with
RPL554 to date, with 299 subjects enrolled. RPL554 has been
observed to provide clinically meaningful and statistically
significant improvements in lung function as both a single agent
and as an add-on therapy with currently marketed bronchodilator
drugs. In addition, RPL554 has been observed to shorten the time of
onset of bronchodilation when administered as an add-on therapy
with currently marketed bronchodilators, and has also shown
anti-inflammatory effects. RPL554 has been well tolerated in each
of its clinical trials. Verona Pharma also intends to pursue
development of RPL554 to address multiple other respiratory
diseases, including asthma.
About The Cystic Fibrosis Trust
The Cystic Fibrosis Trust is the only UK-wide charity making a
daily difference to the lives of people with cystic fibrosis, and
those who care for them. Since its start in 1964 it has dedicated
itself to promoting excellence in research and clinical care, as
well as providing practical support and advice to people with
cystic fibrosis and their families. The Trust believes that
everyone with cystic fibrosis deserves the best quality of life and
real hope for the future, with access to high quality, specialist
care. To achieve this goal, it funds research to better understand
and treat cystic fibrosis, review standards of cystic fibrosis
care, and provide information and advice to the CF community.