Verona Pharma plc Verona Pharma Initiates Phase 2 Clinical Trial Evaluating Nebulized Rpl554 As Add-on To Dual Bronchodilator...

 
TIDMVRP TIDMVRP 
 
 
   This three-way crossover study will inform design of pivotal Phase 3 
trials 
 
   Top line data expected first quarter 2019 
 
   LONDON, Aug. 01, 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 the initiation of a Phase 2 clinical 
trial evaluating the effect of nebulized RPL554 as an add-on to 
treatment with dual long-acting anti-muscarinic / long-acting 
beta2-agonist drugs ("LAMA/LABA"), which are commonly used in the 
maintenance treatment of patients with moderate to severe chronic 
obstructive pulmonary disease ("COPD"). The first patients have been 
enrolled and dosed in the study, and top line data are expected in the 
first quarter of 2019. 
 
   RPL554 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 COPD and for the treatment of cystic fibrosis 
("CF"). 
 
   The randomized, double-blind, three-way crossover trial, being conducted 
at sites in the U.S. and in the U.K., will enroll approximately 75 
patients with COPD to investigate the efficacy and safety of nebulized 
RPL554 as an add-on to an inhaled LAMA/LABA, tiotropium/olodaterol 
(Stiolto(R)  Respimat(R) ), compared to placebo. Those patients already 
receiving inhaled corticosteroid ("ICS") anti-inflammatory therapy will 
continue a stable dose of ICS throughout the study, thus providing 
additional data on "triple therapy" use. Following a 7- to 14-day 
washout period in advance of dosing and between study arms, patients 
will receive three days of treatment with each of two dose strengths 
(1.5 mg or 6.0 mg) of nebulized RPL554 or placebo twice daily. The 
primary endpoint of this trial is improvement in lung function with 
RPL554 vs placebo (as add-on to tiotropium/olodaterol), as measured by 
peak forced expired volume in one second (FEV(1) )(,) a standard measure 
of exhaled breath volume to evaluate respiratory function. 
 
   "We have already demonstrated that RPL554 is an effective add-on 
treatment to short- and long-acting bronchodilators in COPD patients. 
This Phase 2 trial will now examine the effect of RPL554 as an add-on to 
LAMA/LABA therapy, and in some patients to triple therapy, as many of 
these COPD patients continue to experience breathing difficulties and 
daily symptoms that impair their quality of life despite concomitant 
treatment with two bronchodilators. We believe the bronchodilator and 
anti-inflammatory properties of RPL554 may be particularly useful in 
this large group of patients with high, unmet medical need. This phase 2 
trial is intended to provide important data to inform the design of 
pivotal Phase 3 studies with RPL554, expected to commence later next 
year," said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. 
 
   About COPD 
 
   Chronic obstructive pulmonary disease ("COPD") is a progressive and 
life-threatening respiratory disease for which there is no cure.(1) 
Although COPD is thought to be underdiagnosed, globally, around 384 
million people suffer from the disease.(2)  This number, according to 
the World Health Organization ("WHO"), is likely to increase in coming 
years, with estimates that COPD will become the third leading cause of 
death worldwide by 2030.(1,[3])  The condition damages the airways and 
the lungs, leading to persistent symptoms of breathlessness, impacting a 
person's daily life and their ability to perform simple activities such 
as walking a short flight of stairs or carrying a suitcase.(1)  Many 
experience acute periods of worsening symptoms called 'exacerbations', 
often leading to emergency department visits or hospital admissions and 
are also associated with high mortality.(4)  In the United States alone, 
the 2010 total annual medical costs related to COPD were estimated to be 
$32 billion and are projected to rise to $49 billion in 2020.(5)  About 
30-40% of moderate to severe COPD patients on triple inhaled therapy 
(ICS/LAMA/LABA) remain uncontrolled and continue to experience airway 
obstruction (breathing difficulties), COPD symptoms and 
exacerbations.(6)  There is an urgent need for drugs with novel 
mechanisms of action that can be used by these patients in addition to 
current therapies. 
 
   About Verona Pharma plc and RPL554 
 
 
   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 
previous clinical trials, RPL554 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. RPL554 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, 
RPL554 has shown anti-inflammatory effects in a standard challenge study 
with COPD-like inflammation in human subjects. RPL554 has been well 
tolerated in these studies and has a favorable safety and tolerability 
profile, having been administered to more than 730 subjects in 12 
clinical trials. 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 2 clinical trial of RPL554, the timing of availability of top-line 
data for the Phase 2 clinical trial, the importance of the Phase 2 
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 2 
clinical trial, including for the purpose of designing pivotal Phase 3 
trials. 
 
   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 and the 
completion of our Phase 2 trial; we may not be successful in developing 
RPL554 for multiple indications; our ability to obtain regulatory 
approvals necessary to conduct later stage trials and to commercialize 
RPL554 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 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 Annual Report on Form 20-F filed with the Securities and 
Exchange Commission ("SEC") on February 27, 2018 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 
 
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)
James Heins Tel: +1 203-682-8251
James.Heins@icrinc.com
Stephanie Carrington Tel. +1 646-277-1282
Stephanie.Carrington@icrinc.com

(1) World Health Organization. Chronic Obstructive Pulmonary Disease.
http://www.who.int/mediacentre/factsheets/fs315/en/. Accessed September
2017.

(2) Adeloye D, Chua S, et al. Global and regional estimates of COPD
prevalence: Systematic review and meta-analysis. J Glob Health 2015;
5(2): 020415.

(3) World Health Organization. Burden of COPD.
http://www.who.int/respiratory/copd/burden/en/. Accessed September 2017.

(4) COPD Foundations. Characteristics of COPD Patients Using United
States Emergency Care or Hospitalization.
https://journal.copdfoundation.org/jcopdf/id/1103/Characteristics-of-COPD-Patients-Using-United-States-Emergency-Care-or-Hospitalization.
Accessed September 2017.

(5) Center for Disease Control. Increase Expected in Medical Costs for
COPD. https://www.cdc.gov/features/ds-copd-costs/. Accessed September
2017.

(6) Mullerova H., et al., Characterization of COPD Patients Treated
With Inhaled Triple Therapy Containing Inhaled Corticosteroid [ICS],
Long-Acting Beta2-Agonists [LABA], and Long-Acting Muscarinic
Antagonists [LAMA] in the UK, American Journal of Respiratory and
Critical Care Medicine 2017;195:A4986

(6) Vestbo J, et al., Single inhaler extrafine triple therapy versus
long-acting muscarinic antagonist therapy for chronic obstructive
pulmonary disease (TRINTY); a double-blind, parallel group, randomised
controlled trial, The Lancet, Vol 389, p. 1919-1929; May 13, 2017.

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

August 01, 2018 02:00 ET (06:00 GMT)

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