VRP Verona Pharma Plc

 
TIDMVRP TIDMVRP 
 
 
   June 5, 2017, LONDON - Verona Pharma plc (AIM: VRP) (NASDAQ: VRNA) 
("Verona Pharma"), a clinical-stage biopharmaceutical company focused on 
developing and commercializing innovative therapeutics for the treatment 
of respiratory diseases with significant unmet medical needs, announces 
today the initiation of a clinical pharmacokinetic trial in the United 
States for the Company's product candidate, RPL554, following the 
acceptance of an Investigational New Drug application ("IND") by the 
U.S. Food and Drug Administration ("FDA").  The first subjects have been 
enrolled and dosed in the study. 
 
   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 
treatment of chronic obstructive pulmonary disease ("COPD") and cystic 
fibrosis ("CF"). 
 
   This complete block two-way crossover trial will investigate the oral 
bioavailability and pharmacokinetics ("PK") of nebulized RPL554 in 12 
healthy volunteers. The study will also assess the tolerability and 
safety of single nebulized doses of RPL554. The oral bioavailability 
examines the potential contribution arising from the absorption of the 
swallowed portion of a nebulized dose of RPL554 to its systemic 
bioavailability. Top-line data is expected in the fourth quarter 2017. 
 
   "We are pleased that the IND for RPL554 has been accepted by the FDA and 
to initiate clinical studies with RPL554 in the United States", said 
Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "This study will support 
further development of RPL554 to address unmet clinical needs in 
patients suffering from COPD and other debilitating respiratory 
diseases." 
 
   About Verona Pharma plc 
 
   Verona Pharma is a clinical-stage biopharmaceutical company focused on 
developing and commercialising 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. Verona Pharma is developing RPL554 for the treatment of COPD, 
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. 
 
   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, 
statements regarding the design of the PK clinical trial of RPL554, the 
timing and availability of top-line data for the PK clinical trial, and 
the importance of the PK clinical trial to our development plans for 
RPL554. 
 
   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 
 
N+1 Singer (Nominated Adviser and UK Broker)   Tel: +44 (0)20 7496 3000 
Aubrey Powell / James White 
 
FTI Consulting (UK Media and Investor          Tel: +44 (0)20 3727 1000 
Enquiries) 
Simon Conway / Stephanie Cuthbert /            veronapharma@fticonsulting.com 
 Natalie Garland-Collins 
 
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

June 05, 2017 02:00 ET (06:00 GMT)

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