14 October 2015

Start of RPL554 Phase IIa combination study

VERONA PHARMA PLC - Start of RPL554 Phase IIa combination study

PR Newswire

Verona Pharma plc
("Verona Pharma" or the "Company")

Verona Pharma announces start of RPL554 Phase IIa combination study

First COPD patients dosed with RPL554 on top of salbutamol and ipratropium
Headline data expected Q2 2016

14 October 2015, Cardiff – Verona Pharma plc (AIM: VRP.L), the drug development company focused on first-in-class medicines to treat respiratory diseases, today announces that the first patients have been dosed in a Phase IIa combination study to evaluate the addition of RPL554 to standard reliever medications for chronic obstructive pulmonary disease (COPD).  RPL554 is a novel inhaled PDE3/PDE4 inhibitor with anti-inflammatory as well as bronchodilatory properties, currently in development as a nebulised treatment for acute exacerbations in COPD patients in a hospital or home-care setting.  The nebulised bronchodilator market was worth approximately $1 billion in 2014 in the US.

The primary objective of this study is to evaluate whether RPL554 has an additive bronchodilator effect in COPD patients, when administered in addition to standard of care bronchodilators.  Up to 30 patients will be enrolled in this double-blind, placebo-controlled, six way crossover study, which will investigate the pharmacodynamic effect of nebulised RPL554 in a commercially scalable suspension formulation.  This trial will use spirometry2 and whole body plethysmography3 to compare RPL554 to placebo, when administered with a beta2 agonist (salbutamol), and with a muscarinic antagonist (ipratropium).  The trial is being performed at the Medicines Evaluation Unit in Manchester by lead investigator Professor Dave Singh

As reported on 29 September 2015, Phase IIa results from a prior study using nebulised RPL554 alone in stable COPD patients with moderate severity of disease, showed that, in addition to good tolerability and safety profile, RPL554 caused a pronounced improvement in lung function, as measured by peak FEV1, suggesting the drug produced a clinically meaningful bronchodilator effect.  

Dr Jan-Anders Karlsson, the CEO of Verona Pharma, said:

“We believe RPL554 has the potential to become an important new treatment option for COPD patients.  This latest study will evaluate the potential of RPL554 when added to existing therapies. We recently announced encouraging results from our standalone Phase IIa study, which demonstrated that the new commercially scalable, suspension formulation of RPL554 is well tolerated and has allowed us to extend the dose range and the duration of bronchodilation effect that can be produced in COPD patients.  Headline data from this combination study is expected in Q2 2016.

“We are also evaluating the potential of RPL554 in a Phase IIa trial in asthma patients and look forward to reporting headline data in Q1 next year.” 


1 IMS Consulting Group market research 2014

2 Spirometry is the measurement of lung function through the volume and /or flow of air that can be forcibly exhaled

3 Whole body plethysmography is a technique to measure lung volume and airway resistance

For further information please contact:

Verona Pharma plc Tel: +44 (0)20 7863 3300
Jan-Anders Karlsson, CEO  
N+1 Singer Tel: +44 (0)20 7496 3000
Aubrey Powell / Jen Boorer  
FTI Consulting Tel: +44 (0)20 3727 1000
Simon Conway / Stephanie Cuthbert /
Natalie Garland-Collins

Notes to Editors

About Verona Pharma plc

Verona Pharma plc is a UK-based clinical stage biopharmaceutical company focused on the development of innovative prescription medicines to treat respiratory diseases with significant unmet medical needs, such as chronic obstructive pulmonary disease (COPD), asthma and cystic fibrosis. 

Verona Pharma's lead drug, RPL554, is a first-in-class drug currently in Phase IIa trials as a nebulised treatment for acute exacerbations of COPD in the hospital setting.  The drug is a dual phosphodiesterase (PDE) 3/4 inhibitor and therefore has both bronchodilator and anti-inflammatory effects, which are essential to the improvement of patients with COPD and asthma. 

Verona Pharma is also building a broader portfolio of RPL554-containing products to maximise its benefit to patients and its value.  This includes the very significant markets for COPD and asthma maintenance therapy.  The Company is also exploring the potential of the drug in different diseases, such as cystic fibrosis, where it is in pre-clinical testing and has received a Venture and Innovation Award from the Cystic Fibrosis Trust.

About The Medicines Evaluation Unit

The Medicines Evaluation Unit (“MEU”) is one of the UK's leading contract research organisations, working in collaboration with the University Hospital of South Manchester. The MEU specialises in performing clinical trials (from Phase I through to IV) in respiratory/inflammatory medicine and related areas. The MEU has an outstanding reputation for performing high quality clinical research complying with UK Clinical Trials legislation and EU Directives and holds MHRA Phase I accreditation.

About Chronic Obstructive Pulmonary Disease (COPD)

Sixty-five million people worldwide suffer from moderate to severe COPD and the World Health Organisation (WHO) expects COPD to be the third leading cause of death globally by 2020.  It is the only major chronic disease with increasing mortality.  Currently available drugs are aimed at long-term maintenance therapy, with the market dominated by large pharma.  Despite the wide availability of these therapies, COPD patients suffer acute periods of worsening symptoms (exacerbations), which cause, in the US alone, some 1.5 million A&E visits, 726,000 hospitalisations and 120,000 deaths per annum.

For further information please contact:


Verona Pharma plc
Jan-Anders Karlsson, CEO
Victoria Stewart, Director of Communications
Tel: +44 (0)20 3283 4200

N+1 Singer (Nominated Adviser and UK Broker)
Aubrey Powell /Jen Boorer /Iqra Amin (Corporate Finance)
Brough Ransom /Mia Gardner (Corporate Broking)
Tel: +44 (0)20 3283 4200



Optimum Strategic Communications
(European Media and Investor enquiries)
Mary Clark, Annemarieke Ezendam
Hollie Vile
Tel: +44 (0) 203 950 9144

Argot Partners (Investor enquiries)
Stephanie Marks
Tel. +1 646 644 9590


Verona Pharma plc
3 More London Riverside, London SE1 2RE
T: +44 (0)203 283 4200

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