Verona Pharma plc Verona Pharma Announces Positive Top-Line Data From Phase 2a Clinical Trial In Copd With Rpl554 Dosed In Ad...

 
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 [phone] for callers in the United States 
 
   -- 0800 279 4841 or [phone] for callers in the United Kingdom 
 
   -- 0800 589 2674 or [phone] 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: [phone] 
 
   [e-mail] 
 
   Stifel Nicolaus Europe Limited (Nominated Adviser and UK Broker) 
 
   Stewart Wallace / Jonathan Senior / Ben Maddison 
 
   Tel: [phone] 
 
   [e-mail] 
 
   FTI Consulting (UK Media and Investor enquiries) 
 
   Simon Conway / Natalie Garland-Collins 
 
   Tel: [phone] 
 
   [e-mail] 
 
   ICR, Inc. (US Media and Investor enquiries) 
 
   James Heins 
 
   Tel: [phone] 
 
   [e-mail] 
 
   Stephanie Carrington 
 
   Tel. [phone] 
 
   [e-mail] 
 
   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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