Verona Pharma plc Verona Pharma Reports Positive Top-Line Data From U.S. Pharmacokinetic Trial Demonstrating Nebulized Rpl554...

 
TIDMVRP 
 
 
   Earlier than expected results demonstrate absorption occurs primarily in 
the lungs following inhaled administration 
 
   LONDON, Sept.  27, 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 top-line results from its 
clinical pharmacokinetic (PK) trial in the United States demonstrating 
that inhaled RPL554 is an appropriate form of administration for 
patients with chronic obstructive pulmonary disease (COPD) and other 
respiratory disorders. 
 
   With any inhaled or nebulized medication, a portion of the substance is 
deposited in the mouth and then swallowed by the patient. These results 
show 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 
confirm that inhaled RPL554 is an appropriate form of administration for 
patients. 
 
   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, and Verona Pharma is 
reporting top-line results earlier than expected. 
 
   Highlights 
 
 
   -- Primary outcome measures: 
 
          -- 10.4 percent of nebulized RPL554 reached the bloodstream via the 
             gastrointestinal tract demonstrating suitability for inhaled 
             administration. 
 
          -- 11.9 hour half-life in blood is consistent with earlier data and 
             supports twice-daily dosing of RPL554. 
 
   -- Secondary outcome measures: 
 
          -- Low oral bioavailability and blood levels of RPL554, as a result 
             of swallowed medication, suggest limited contribution to systemic 
             effects of inhaled medication in the lungs. 
 
          -- RPL554 was well tolerated by all subjects without any evidence of 
             safety concerns. 
 
 
   "These data demonstrate that inhalation of RPL554 is an appropriate 
route of administration for people with COPD and other respiratory 
diseases. The low oral bioavailability seen in this PK trial reinforces 
that the swallowed portion of the medication contributes very little to 
the effects of RPL554. The inhaled portion provides novel bronchodilator 
and anti-inflammatory effects, and has limited systemic exposure," said 
Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "We believe that our 
ability to consistently deliver higher doses of RPL554 directly to the 
lungs, while at the same time having only low levels in the bloodstream, 
is consistent with a promising therapeutic effect, and we continue to 
see good tolerability of the compound across our clinical trials." 
 
   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 in combination with 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. 
 
   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.(1,[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 U.S. 
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 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 delivery of higher 
doses of RPL554 to the lungs having a promising therapeutic effect, 
estimates that COPD will be the third leading cause of death worldwide 
by 2030, 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 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                                    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     SNELVeronaPharma@stifel.com 
 
FTI Consulting (UK Media and Investor enquiries)     Tel: +44 (0)20 3727 1000

Simon Conway / Stephanie Cuthbert / veronapharma@fticonsulting.com
Natalie Garland-Collins mailto: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.

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 27, 2017 02:00 ET (06:00 GMT)

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