VRP Verona Pharma Plc

Verona Pharma plc

("Verona Pharma" or the "Company")

Completion of patient enrolment in two RPL554 Phase IIa studies, ahead of expected timeline

Headline data expected in Q1 2016 and Q2 2016

5 November 2015, Cardiff – Verona Pharma plc (AIM: VRP.L), the drug development company focused on first-in-class medicines to treat respiratory diseases, today announces it has completed patient enrolment for the Phase IIa dose-finding study of RPL554 in asthma and the Phase IIa combination study of RPL554 in chronic obstructive pulmonary disease (COPD), in which the drug is being administered in addition to standard of care bronchodilators.  Headline data is expected Q1 2016 for the asthma study and Q2 2016 for the COPD combination study.

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.¹ 

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 are very pleased to have completed recruitment in both of these studies ahead of our plan. We believe the results will continue to build on the positive data recently announced from our  Phase I/IIa study, which demonstrated that the new commercially scalable, suspension formulation of RPL554 is well tolerated and that the extent of the bronchodilation exceeded that seen in earlier studies with the prior formulation.  We believe RPL554 has the potential to become an important new treatment option for both COPD and asthma patients and look forward to reporting headline data from both studies in the first half of next year.” 

About the studies

Phase IIa study of RPL554 asthma patients

In this study 29 patients with mild to moderate persistent asthma will each receive single doses of nebulised RPL554, from the very low dose to the highest dose previously tested in the Phase Ib single ascending and multiple ascending dose (SAD and MAD) studies of the same drug in healthy subjects.  In this double-blind, placebo-controlled, crossover study, each patient will also receive two different doses of nebulised salbutamol, a commonly used bronchodilator in these patients, and placebo.  The primary objective of the trial is to establish the dose-dependency of the bronchodilator effect and the duration of action of RPL554 in asthma patients.  The study is being performed at Celerion (Belfast, Ireland) and Skane University Hospital (Lund, Sweden). 

Phase IIa combination study of RPL554 in COPD patients

The primary objective of this study is to evaluate whether RPL554 has an additive bronchodilator effect and is well tolerated in COPD patients, when administered in addition to standard of care bronchodilators. Thirty patients have been 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. 

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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 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. 

References

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