5 June 2017

Verona Pharma Initiates U.S. Clinical Pharmacokinetic Study for RPL554 Following Acceptance of IND Application by FDA

LONDON, June 05, 2017 (GLOBE NEWSWIRE) -- 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 Enquiries)       Tel: +44 (0)20 3727 1000
Simon Conway / Stephanie Cuthbert /
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 

 

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Verona Pharma plc

For further information please contact:

 

Verona Pharma plc
Jan-Anders Karlsson, CEO
Tel: +44 (0)20 3283 4200
info@veronapharma.com

N+1 Singer (Nominated Adviser and UK Broker)
Aubrey Powell / James White
Tel: +44 (0)20 7496 3000

 

 

FTI Consulting
Simon Conway / Stephanie Cuthbert / Natalie Garland-Collins
Tel: +44 (0)20 3727 1000
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


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T: +44 (0)203 283 4200

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