TIDMVRP
Achieved statistically significant and clinically meaningful additional
improvement in peak lung function and faster onset-of-action in COPD
patients with RPL554 when added to tiotropium
LONDON, May 22, 2018 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM:VRP)
(Nasdaq:VRNA) ("Verona Pharma" or "the Company"), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for respiratory diseases, today presented Phase 2a
and pharmacokinetic data from two clinical trials evaluating its lead
product candidate, RPL554, in chronic obstructive pulmonary disease
(COPD) at the American Thoracic Society International Conference (ATS
2018), in San Diego. Results from these trials were previously reported
by Verona Pharma on September 7, 2017
https://globenewswire.com/news-release/2017/09/07/1108710/0/en/Verona-Pharma-Announces-Positive-Top-Line-Data-from-Phase-2a-Clinical-Trial-in-COPD-with-RPL554-Dosed-in-Addition-to-Tiotropium-Spiriva.html
and September 27, 2017
https://globenewswire.com/news-release/2017/09/27/1133508/0/en/Verona-Pharma-Reports-Positive-Top-Line-Data-from-U-S-Pharmacokinetic-Trial-Demonstrating-Nebulized-RPL554-Delivers-Optimal-Clinical-Dose-to-Patients.html
, respectively.
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 and for the treatment of cystic fibrosis.
The poster, titled, "RPL554, A First-In-Class Dual PDE3/4 Inhibitor,
Causes Rapid Additional Bronchodilation When Dosed with Tiotropium in
COPD Patients," provided a review of the positive data from Verona
Pharma's Phase 2a clinical trial, in which RPL554 was dosed in addition
to tiotropium (Spiriva(R) ), one of the most commonly used drugs to
treat COPD. In summary, 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 measures1: -- 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 (1.5 mg, 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%
In addition, Verona Pharma presented data at ATS from its
pharmacokinetic trial with RPL554 in a poster titled, "Low Oral
Bioavailability of RPL554, a First-in-Class Dual PDE3/4 Inhibitor,
Demonstrates that its Nebulized, Inhaled Formulation is Appropriate for
Delivering Optimal Pulmonary Dose," which showed that inhaled RPL554 is
an appropriate form of administration for patients with COPD and other
respiratory disorders.
This complete block two-way crossover trial evaluated a single dose of
RPL554 in 12 healthy volunteers to determine the process of bodily
absorption, distribution, metabolism and excretion of this novel therapy,
including the swallowed portion of the nebulized dose. The trial was
conducted under an Investigational New Drug application accepted by the
U.S. Food and Drug Administration in June 2017.
With any inhaled or nebulized medication, a portion of the substance is
deposited in the mouth and then swallowed by the patient. These results
showed that in the study subjects, only 10.4 percent of the inhaled dose
entered the bloodstream via the gastrointestinal tract. The low oral
bioavailability of nebulized RPL554, as demonstrated in the study, is
consistent with optimal inhaled delivery of medications for the
treatment of COPD and asthma. Therefore, the results from this study
confirmed that inhaled RPL554 is an appropriate form of administration
for patients.
Dave Singh, M.D., Professor of Clinical Pharmacology and Respiratory
Medicine, Medicines Evaluation Unit, University of Manchester, presented
the RPL554 with tiotropium data at ATS and commented, "These encouraging
data warrant further investigation of RPL554 to meet the urgent need for
drugs with novel mechanisms of action that can be used in addition to
current therapies, in order to provide further treatment of both COPD
symptoms and exacerbations."
"These positive data are further evidence of RPL554's promising
therapeutic potential for the treatment of COPD patients, further
supporting Verona's ongoing clinical development program," said
Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "We look forward to
advancing development of this first-in-class treatment this year by
initiating in the third quarter a Phase 2a clinical trial to evaluate
RPL554 when dosed in addition to LAMA/LABA therapy or triple therapy,
compared to placebo. We also plan this year to complete pre-clinical
studies for RPL554 delivered as both pressurized metered dose inhaler
and dry powder inhaler formulations, followed by clinical trials in
healthy subjects or patients with COPD targeted to commence in the first
quarter of 2019."
In March 2018, the Company reported positive top-line results from a
Phase 2b trial for the maintenance treatment of COPD. The study met its
primary endpoint, with RPL554 producing a clinically and statistically
significant improvement in FEV(1) at four weeks in patients with
moderate-to-severe COPD compared to placebo. Furthermore, the peak
FEV(1) was significantly improved at all time points over the four
weeks of dosing. Secondary endpoints measuring 12 hour average FEV(1) ,
progressive improvement in COPD symptoms and Quality of Life were also
met and support the potential clinical benefits of RPL554 for the
treatment of COPD. RPL554 was well tolerated at all doses with an
adverse event profile similar to placebo.
(__________________________) (3) Dyspnea (shortness of breath) in COPD
patients is often associated with hyperinflation of the lungs resulting
from a higher residual volume of air
About COPD
Chronic obstructive pulmonary disease (COPD) is a progressive and
life-threatening respiratory disease for which there is no cure.(1) The
condition damages the airways and the lungs, leading to persistent
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) 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) Current COPD therapies
focus on reducing and controlling symptoms. Yet, despite the wide
availability of these treatments, many patients continue to suffer acute
periods of worsening symptoms known as exacerbations. These
exacerbations often lead 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 Verona Pharma plc
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
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 administered in addition
to frequently used short- and long-acting bronchodilators as compared to
such bronchodilators administered as a single agent. 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 value of the
results from the Phase 2a and pharmacokinetic clinical trials, RPL554 as
a new complementary treatment for patients with COPD, projected annual
medical costs related to COPD, the results of the Phase 2a and
pharmacokinetic trials supporting later stage development of RPL554, the
future clinical development and positioning of RPL554, and the treatment
potential for RPL554.
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 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.
__________________________
(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) Centers for Disease Control. Increase Expected in Medical Costs for
COPD. https://www.cdc.gov/features/ds-copd-costs/. Accessed September
2017.
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
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
May 22, 2018 02:03 ET (06:03 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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