Verona Pharma PLC Second Venture and Innovation Award from the CF Trust

 
TIDMVRP 
 
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. 
 
 
 
END
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