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Verona Pharma Release: First Patient Dosed in Clinical Trial to Further Evaluate Efficacy of VRP700 as a Treatment for Chronic Severe Cough



6/24/2013 9:28:56 AM

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June 24, 2013 -- Verona Pharma plc (AIM: VRP), the drug development company focused on “first-in-class” medicines to treat respiratory diseases, today announces that the first patient in a clinical trial to further evaluate the efficacy of VRP700 as a novel treatment for chronic severe cough has been dosed with the drug. In this randomised, double-blind, placebo-controlled crossover study, a total of 20 adults with idiopathic pulmonary fibrosis (IPF) will be treated, by inhalation, with a single nebulized dose of VRP700. Patients with IPF typically cough many times per hour and the efficacy of the drug in these patients will be assessed by measuring the change in frequency and severity of their cough. It is anticipated that data from this clinical trial will be available in H1 2014.

The Principal Investigator for the trial is Dr. Jacky Smith, Centre of Respiratory and Allergy, University of South Manchester, UK. Dr. Smith, an expert in the testing of novel anti-tussive therapies, has developed a specialist clinic investigating and diagnosing patients with chronic cough.

In September 2011, Verona Pharma reported the successful outcome of an initial double-blind, cross-over, placebo-controlled study to assess the anti-tussive effects of VRP700 in a small group of patients with chronic severe cough due to underlying lung disease. This study met both its primary endpoint of a statistically significant reduction in the number of coughs recorded compared to placebo and pre-treatment values, as well as all secondary endpoints. No treatment-related adverse effects were recorded.

Preclinical studies on VRP700 suggest that the drug suppresses cough by a novel, peripherally-acting mechanism in the lung. Other commercially available anti-tussives have poor activity and are centrally-acting which has consequences for their side effect profile and long-term use.

Verona Pharma CEO, Dr. Jan-Anders Karlsson, commented “Verona Pharma is focused on developing first-in-class medicines to treat significant unmet needs in respiratory disease. VRP700 is a novel inhaled drug that has already demonstrated an initial proof of concept in a small clinical study as a treatment for chronic severe cough. We now seek to confirm this result in a larger trial involving patients with IPF.

“Patients with idiopathic pulmonary fibrosis have a persistent troublesome cough. This symptom is a significant contributory factor to the poor quality of life of those with this debilitating orphan disease. There is no effective treatment available for such chronic severe cough.”

For further information please contact:

Verona Pharma plc Tel: 020 7863 3300

Clive Page, Chairman

Jan-Anders Karlsson, CEO

WH Ireland Limited Tel: 020 7220 1666

Chris Fielding

Nick Field

FTI Consulting Tel: 020 7831 3113

Julia Phillips

Simon Conway

About Verona Pharma plc

Verona Pharma is developing first-in-class drugs to treat respiratory disease, such as COPD, asthma and chronic, severe cough. The Company has three drug programmes, two of which are in Phase II. The lead programme, RPL554, is an innovative dual phosphodiesterase (PDE) 3 and 4 inhibitor with both bronchodilator and anti-inflammatory properties. VRP700 is an innovative product for suppressing chronic, severe cough in patients with underlying lung disease. In its third programme, Verona Pharma is investigating novel anti-inflammatory molecules, called NAIPs, for a wide range of respiratory and inflammatory diseases.

About RPL554 for the treatment of COPD and Asthma

Verona’s lead drug, RPL554, is a dual phosphodiesterase (PDE) 3 and 4 inhibitor being developed as a novel treatment for chronic obstructive airways disease such as COPD and asthma with bronchodilator and anti-inflammatory effects. Both effects are essential to improve symptoms in patients with COPD or asthma. RPL554 is currently in phase II for both diseases.

COPD is a chronic lung disease with significant unmet need for which current treatment is far from optimal, as it often has unwanted side-effects and/or limited effectiveness. COPD is most commonly characterised by fixed airflow obstruction and chronic airways inflammation resulting from exposure to irritants like tobacco smoke. Asthma, which remains one of the most common chronic diseases in the world, is characterised by recurrent breathing problems and symptoms such as breathlessness, wheezing, chest tightness, and coughing. The market for COPD and asthma drugs is currently estimated to be GBP20 billion [source: visiongain].

About VRP700 for the treatment of Cough

VRP700 is Verona Pharma's lead drug compound for the treatment of cough, having a novel mechanism of action involving the suppression of cough initiating signals originating from cough sensory nerve endings located in the lungs. A clinical trial completed at the University of Florence, Italy in September 2011 clearly demonstrated significant anti-tussive effects with nebulised VRP700 in hospitalized patients with chronic severe cough.

Cough can be a very debilitating comorbidity reported by patients, especially those with respiratory conditions such as asthma, COPD, lung cancer, interstitial lung disease, fibrosis or lung infections. It is a neglected symptom which is often self-medicated. Consumer spending on OTC medications, including those for cough, grew by 10% over 2005-10, to reach GBP532 million in the UK [source: Mintel]. However, there is very little clinical evidence for such OTC cough medications being really effective and it is widely recognised by the medical community that there is a large need for more effective drugs to control and prevent pathologically induced coughing.

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