Verona Pharma plc Verona Pharma Reports Positive Top-Line Data From Phase 2b Clinical Trial Of Rpl554 For Maintenance Treatme...

 
TIDMVRP 
 
 
   Primary endpoint met; RPL554 produced clinically and statistically 
significant improvements in lung function at all dose levels 
 
   Clinically relevant secondary endpoints were also met, including 
statistically significant, progressive improvements in COPD symptoms 
 
   RPL554 was well tolerated at all dose levels in this four week 400 
patient study 
 
   Management to hold conference call and webcast today at 8 am EDT / 1 pm 
BST 
 
   LONDON, March 26, 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, announces today positive 
top-line data from its Phase 2b study evaluating RPL554, a 
first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 
3 and 4 with bronchodilator and anti-inflammatory properties, as a 
maintenance treatment for chronic obstructive pulmonary disease (COPD). 
 
   The study met its primary endpoint, with RPL554 producing a clinically 
and statistically significant improvement in peak forced expiratory 
volume in one second (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) , 
COPD symptoms and Quality of Life were also met and support the 
potential clinical benefits of RPL554 for the treatment of COPD. 
 
   The four-week, double-blind, placebo-controlled, parallel group, Phase 
2b multicenter European study performed in the out-patient setting 
evaluated the efficacy, safety, and dose-response of nebulized RPL554 
administered twice-daily as a maintenance treatment for COPD in 403 
patients with moderate-to-severe COPD. There were four dosing arms of 
RPL554 (0.75 mg, 1.5 mg, 3.0 mg and 6.0 mg) in the study in addition to 
placebo and patients were required to withhold use of regular 
long-acting bronchodilator therapy for the duration of the study. 
 
   Highlights 
 
   Primary endpoint: 
 
 
   -- RPL554 met the primary endpoint at all doses, showing a statistically 
      significant difference vs. placebo (p<0.001) with absolute changes from 
      baseline >200mL in peak FEV1 after 4 weeks of dosing. No minimum 
      effective dose could be determined. 
 
   -- This peak bronchodilator effect was observed at the first dose and was 
      sustained over four weeks (p<0.001). 
 
 
   Secondary endpoints include: 
 
 
   -- Statistically significant improvements in average FEV1 over 12 hours were 
      observed at all doses after the first administration, and this effect was 
      sustained over four weeks. 
 
   -- This study did not demonstrate consistent improvements in trough FEV1. 
 
   -- Recording of daily COPD symptoms, using E-RS (EXACT-PRO)1, demonstrated a 
      significant improvement in total COPD symptoms (p<0.002), including 
      improvements in breathlessness (p<0.02), chest symptoms (p<0.02), and 
      cough and sputum (p<0.02). 
 
   -- Strong trend of improvement in SGRQ-C2 of >2.5 units was observed in all 
      dose groups after four weeks. 
 
   -- Patients' Global Impression of Change3 indicates that patients felt 
      better on RPL554 compared to placebo (p<0.01). 
 
   -- RPL554 was well tolerated at all doses with an adverse event profile 
      similar to placebo. 
 
 
   Dave Singh, M.D., Professor of Clinical Pharmacology and Respiratory 
Medicine, Medicines Evaluation Unit, University of Manchester, a Lead 
Investigator in the study, commented, "The results from this relatively 
large and well-designed study are very encouraging and clinically 
meaningful. The large and sustained improvement in lung function and 
reduction in COPD symptoms, including reduction in breathlessness, are 
particularly noteworthy. When coupled with the drug's unique mechanism 
of action, these data underline the potential for RPL554 as a new 
complementary treatment for patients with this progressive and 
debilitating disease, where there remains a high unmet medical need." 
 
   Verona Pharma's CMO, Ken Newman, M.D. said, "I am delighted that we met 
the primary endpoint of peak FEV(1) , confirming the strong 
bronchodilator effect of RPL554 in COPD patients. The clinically 
meaningful improvement in daily reported COPD symptom scores in all 
sub-domains, that continued to improve over the four week treatment 
period, is particularly exciting and promising." 
 
   "These results are very encouraging and strongly support the progression 
of RPL554 into later stage development as an inhaled treatment for COPD 
patients", said Jan-Anders Karlsson, PhD., CEO of Verona Pharma. "The 
future clinical development and the positioning of this novel treatment 
will be informed by these data as well as by the outcome of the clinical 
study as an add-on to established combination therapies planned to start 
this year, and our ongoing market research". 
 
   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. In addition, RPL554 has 
shown anti-inflammatory effects in a standard challenge study with 
COPD-like inflammation in human subjects. In these studies, RPL554 has 
been well tolerated. RPL554 also has a favorable safety and tolerability 
profile, having been administered in more than 730 subjects in 12 
clinical trials. 
 
   1 E-RS (EXACT-PRO) - a recognized patient-reported outcome measure for 
use in clinical studies of COPD. 
 
   2 SGRQ-C - St. George's Respiratory Questionnaire designed to measure 
impact on overall health, daily life, and perceived well-being in 
patients with COPD. 
 
   3 Patients' Global Impression of Change - a scale reflecting the 
patient's belief about the efficacy of treatment. 
 
   Conference Call 
 
   Verona Pharma will host an investment community conference call today at 
8:00 a.m. Eastern Daylight Time (1:00 p.m. British Summer Time) to 
discuss the positive top-line data from the Phase 2b clinical trial in 
COPD disclosed in this press release. 
 
   Analysts and investors may participate in the conference call by 
utilizing the conference ID: 13677941 and dialing the following numbers: 
 
 
   -- 1-877-423-9813 or + 1-201-689-8573 for callers in the United States 
 
   -- 0 800 756 3429 for callers in the United Kingdom 
 
   -- 0 800 182 0040 for callers in Germany 
 
 
   Those interested in listening to the conference call live via the 
internet may do so by visiting the "Events and Presentations" page on 
the "Investors" section of Verona Pharma's website at 
http://investors.veronapharma.com/events-and-presentations/events and 
clicking on the webcast link.  Slides highlighting the top-line data 
will also be posted to the "Events and Presentations" page. 
 
   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 
top-line results from the Phase 2b clinical trial, RPL554 as a new 
complementary treatment for patients with COPD, projected annual medical 
costs related to COPD, the results of the Phase 2b trial 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.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF
ARTICLE 7 OF REGULATION (EU) NO 596/2014.

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) SNELVeronaPharma@stifel.com
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.

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/

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March 26, 2018 02:00 ET (06:00 GMT)

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