Achieved significant and clinically meaningful
additional improvement in peak lung function and faster
onset-of-action when added to tiotropium
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®), 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 (FEV1) on the third day of dosing and the average FEV1
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®).
- 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 FEV1 improvement by ≥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 GOLD4 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
DiseaseChronic 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 plcVerona 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 StatementsThis
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 plcJan-Anders Karlsson, Chief
Executive OfficerTel: +44 (0)20 3283
4200info@veronapharma.com
Stifel Nicolaus Europe Limited (Nominated
Adviser and UK Broker)Stewart Wallace / Jonathan Senior / Ben
MaddisonTel: +44 (0) 20 7710
7600SNELVeronaPharma@stifel.com
FTI Consulting (UK Media and Investor
enquiries)Simon Conway / Natalie Garland-CollinsTel: +44 (0)20 3727
1000 veronapharma@fticonsulting.com
ICR, Inc. (US Media and Investor enquiries)James
HeinsTel: +1 203-682-8251James.Heins@icrinc.com
Stephanie CarringtonTel. +1
646-277-1282Stephanie.Carrington@icrinc.com
THIS ANNOUNCEMENT CONTAINS INSIDE
INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO
596/2014.
Verona Pharma (LSE:VRP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Verona Pharma (LSE:VRP)
Historical Stock Chart
From Jul 2023 to Jul 2024