Verona Pharma plc Verona Pharma Announces Positive Top-Line Data From Phase 2a Clinical Trial In Copd With Rpl554 Dosed In Ad...
September 07 2017 - 1:00AM
UK Regulatory
TIDMVRP
Achieved significant and clinically meaningful additional improvement in
peak lung function and faster onset-of-action when added to tiotropium
Demonstrated statistical significance across all primary and secondary
efficacy outcome measures, at 6 mg dose; a clear dose response compared
to 1.5 mg dose
Management to hold conference call and webcast today at 8 am EDT time /
1 pm BST
LONDON, Sept. 07, 2017 (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 positive top-line results from
its Phase 2a clinical trial, in which RPL554 was dosed in addition to
tiotropium (Spiriva(R) ), one of the most commonly used drugs to treat
chronic obstructive pulmonary disease (COPD). In summary, despite the
limited number of patients, the data from this Phase 2a trial
demonstrated significantly improved peak lung function when RPL554 was
added to tiotropium in patients with moderate-to-severe COPD.
This was a double blind, placebo-controlled, three way cross-over trial
in 30 subjects with COPD and included two different doses of RPL554, 1.5
mg and 6 mg, or placebo, dosed twice-daily for three days, in addition
to tiotropium, a long-acting anti-muscarinic (LAMA) bronchodilator,
dosed once daily (ClinicalTrials.gov Identifier: NCT03028142). The
primary outcome measures for the trial were peak forced expired volume
in one second (FEV(1) ) on the third day of dosing and the average
FEV(1) on the third day of dosing, representing measures of lung
function and duration of effect. A number of secondary outcome measures
were also recorded. Of note, the 6 mg dose of RPL554 achieved
statistical significance, compared to placebo, on all primary and
secondary outcome measures. The data confirmed dose dependency between
the two RPL554 doses.
Highlights
-- Primary outcome measures 1 :
-- RPL554, compared to placebo, produced a statistically significant
(1.5 mg, p=0.002; 6 mg, p<0.001) and a clinically meaningful (>100
ml) peak FEV1 on the third day of dosing (additional
bronchodilation) when administered on top of the standard
bronchodilator tiotropium (Spiriva(R)).
-- Average FEV1 on the third day of dosing (0 - 12 hours) of RPL554
when added on top of tiotropium was larger than that of tiotropium
alone (1.5mg, p=0.099; 6 mg, p<0.001).
-- Secondary outcome measures:
-- Both doses of RPL554 produced a statistically significant faster
onset of action2 (1.5 mg, 4.2 min; 6 mg, 4.6 min) when added to
tiotropium compared to tiotropium alone (37.6 min; p<0.001)
-- The administration of RPL554 as an add-on treatment to tiotropium
caused a marked reduction in Functional Residual Capacity (1.5 mg,
p<0.01; 6 mg, p<0.05) and in Residual Volume (1.5 mg, p=0.07; 6 mg,
p<0.01), both measures of trapped air in the lung, as compared to
tiotropium alone
-- Suggesting that RPL554 treatment may reduce dyspnea, a
major debilitating symptom of COPD3.
-- Both doses of RPL554 were well tolerated as add-on treatments to
tiotropium.
-- Adverse reactions were consistent with previous studies with
RPL554 and tiotropium. No cardiovascular-related or
gastrointestinal related adverse reactions were reported.
(__________________)
(1) In the study, a p-value<0.05 is regarded as statistically
significant
(2) Defined as FEV(1) improvement by greater than or equal to 10%
(3) Dyspnea (shortness of breath) in COPD patients is often associated
with hyperinflation of the lungs resulting from a higher residual volume
of air
Dave Singh, M.D., Professor of Clinical Pharmacology and Respiratory
Medicine, Medicines Evaluation Unit, University of Manchester and
Principal Investigator in this trial, commented, "Top-line results from
this Phase 2a study demonstrate the very significant improvement in lung
function that can be achieved in COPD patients using RPL554 in addition
to tiotropium, the most widely used LAMA treatment. These encouraging
results reinforce the potential for RPL554 to provide a meaningful
difference in the treatment of COPD patients."
"We are pleased that RPL554 demonstrated a significant and clinically
meaningful improvement in lung function of COPD patients and speeds up
onset of action when it is administered as an add-on treatment to one of
the most widely prescribed LAMA bronchodilators in these patients. LAMAs
are the mainstay of all regimens under the GOLD(4) treatment
guidelines. We observed a clear dose response with the 6 mg dose,
achieving statistical significance on all of the primary and secondary
endpoints," said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "These
findings extend our previous data and show that RPL554 has the potential
to further improve lung function when administered as an add-on
treatment to both short-acting and long-acting bronchodilators. We
continue to enroll patients in our Phase 2b study to assess nebulized
RPL554 for the maintenance treatment of COPD, and the data from the
current study further affirms our belief that RPL554 can become a
valuable addition to drugs commonly used by patients with COPD."
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 cystic fibrosis.
In previous clinical trials, RPL554 has been observed to result in
bronchodilatory effects when used alone or as an add-on treatment to
other COPD bronchodilators. These trials have shown clinically
meaningful and statistically significant improvements in lung function
when RPL554 is added to two commonly used bronchodilators, as compared
to the improvements in lung function when either bronchodilator is
administered as a single agent. RPL554 has also shown anti-inflammatory
effects in a standard challenge study with COPD-like inflammation in
human subjects. In these studies, RPL554 has been well tolerated.
(____________________)
(4) GOLD (Global initiative for Obstructive Lung Disease) treatment
guidelines - standardized treatment guidelines for COPD based on an
assessment of severity of symptoms
Conference Call
Verona Pharma will host an investment community conference call at today
8:00 a.m. Eastern Daylight Time (1:00 p.m. British Summer Time) to
discuss the positive top-line data from the Phase 2a clinical trial in
COPD disclosed in this press release.
Analysts and investors may participate in the conference call by
utilizing the conference ID: 4242325 and dialing the following numbers:
-- 1-877-280-2342 or +1-718-354-1359 for callers in the United States
-- 0800 279 4841 or +44(0)20 3427 1911 for callers in the United Kingdom
-- 0800 589 2674 or +49(0)69 2222 2221 for callers in Germany
Those interested in listening to the conference call live via the
internet may do so by visiting the "Investors" page of Verona Pharma's
website at www.veronapharma.com and clicking on the webcast link.
Slides highlighting the top-line data are posted to "Events and
Presentations" page on the "Investors" section of Verona Pharma's
website at
http://investors.veronapharma.com/events-and-presentations/events.
The information contained within this announcement is inside information
as stipulated under the MAR. The person responsible for this
announcement on behalf of Verona Pharma is Jan-Anders Karlsson, Chief
Executive Officer.
About Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a progressive
respiratory disease for which there is no cure. The condition damages
the airways and the lungs, leading to cough, mucus secretion and
shortness of breath, impacting a person's ability to perform daily
activities. According to the World Health Organization, COPD is the
third leading cause of death globally, with 210 million people worldwide
suffering from the disease. Current therapies to treat COPD are aimed at
reducing and controlling symptoms. Despite the wide availability of
these therapies, many COPD patients continue to suffer acute periods of
worsening symptoms known as exacerbations. In the U.S. alone, these
exacerbations are associated with approximately 1.5 million emergency
department visits, 687,000 hospitalizations, and 129,000 deaths per
year. The total annual medical costs related to COPD in the U.S. were
estimated to be $32 billion in 2010, and are projected to rise to $49
billion in 2020.
About Verona Pharma plc
Verona Pharma is a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative therapeutics 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 added to two commonly
used bronchodilators as compared to either bronchodilator administered
as a single agent. Verona Pharma is developing RPL554 for the treatment
of chronic obstructive pulmonary disease (COPD), cystic fibrosis, 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 RPL554's ability to
treat dyspnea, RPL554's potential to make a meaningful difference in and
be a valuable addition to the treatment of COPD patients, and RPL554's
potential to improve lung function when administered as an add-on
treatment with bronchodilators..
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; 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
Jan-Anders Karlsson, Chief Executive Officer
Tel: +44 (0)20 3283 4200
info@veronapharma.com
Stifel Nicolaus Europe Limited (Nominated Adviser and UK Broker)
Stewart Wallace / Jonathan Senior / Ben Maddison
Tel: +44 (0) 20 7710 7600
SNELVeronaPharma@stifel.com
FTI Consulting (UK Media and Investor enquiries)
Simon Conway / Natalie Garland-Collins
Tel: +44 (0)20 3727 1000
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
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF
ARTICLE 7 OF REGULATION (EU) NO 596/2014.
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
September 07, 2017 02:00 ET (06:00 GMT)
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