First patient dosed in clinical trial for VRP700

24 June 2013 Verona Pharma plc ("Verona Pharma" or the "Company") First patient dosed in clinical trialto further evaluate efficacy of VRP700 as a treatment for chronic severe cough Verona Pharma plc (AIM: VRP), the drug development company focused on"first-in-class" medicines to treat respiratory diseases, today announces thatthe first patient in a clinical trial to further evaluate the efficacy ofVRP700 as a novel treatment for chronic severe cough has been dosed with thedrug. In this randomised, double-blind, placebo-controlled crossover study, atotal of 20 adults with idiopathic pulmonary fibrosis (IPF) will be treated, byinhalation, with a single nebulized dose of VRP700. Patients with IPF typicallycough many times per hour and the efficacy of the drug in these patients willbe 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 H12014. The Principal Investigator for the trial is Dr. Jacky Smith, Centre ofRespiratory and Allergy, University of South Manchester, UK. Dr. Smith, anexpert in the testing of novel anti-tussive therapies, has developed aspecialist clinic investigating and diagnosing patients with chronic cough. In September 2011, Verona Pharma reported the successful outcome of an initialdouble-blind, cross-over, placebo-controlled study to assess the anti-tussiveeffects of VRP700 in a small group of patients with chronic severe cough due tounderlying lung disease. This study met both its primary endpoint of astatistically significant reduction in the number of coughs recorded comparedto placebo and pre-treatment values, as well as all secondary endpoints. Notreatment-related adverse effects were recorded. Preclinical studies on VRP700 suggest that the drug suppresses cough by anovel, peripherally-acting mechanism in the lung. Other commercially availableanti-tussives have poor activity and are centrally-acting which hasconsequences for their side effect profile and long-term use. Verona Pharma CEO, Dr. Jan-Anders Karlsson, commented "Verona Pharma is focusedon developing first-in-class medicines to treat significant unmet needs inrespiratory disease. VRP700 is a novel inhaled drug that has alreadydemonstrated an initial proof of concept in a small clinical study as atreatment for chronic severe cough. We now seek to confirm this result in alarger trial involving patients with IPF. "Patients with idiopathic pulmonary fibrosis have a persistent troublesomecough. This symptom is a significant contributory factor to the poor quality oflife of those with this debilitating orphan disease. There is no effectivetreatment 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 Notes to Editors 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 drugprogrammes, two of which are in Phase II. The lead programme, RPL554, is aninnovative dual phosphodiesterase (PDE) 3 and 4 inhibitor with bothbronchodilator and anti-inflammatory properties. VRP700 is an innovativeproduct for suppressing chronic, severe cough in patients with underlying lungdisease. In its third programme, Verona Pharma is investigating novelanti-inflammatory molecules, called NAIPs, for a wide range of respiratory andinflammatory diseases. About RPL554 for the treatment of COPD and Asthma Verona's lead drug, RPL554, is a dual phosphodiesterase (PDE) 3 and 4 inhibitorbeing developed as a novel treatment for chronic obstructive airways diseasesuch as COPD and asthma with bronchodilator and anti-inflammatory effects. Botheffects 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 currenttreatment is far from optimal, as it often has unwanted side-effects and/orlimited effectiveness. COPD is most commonly characterised by fixed airflowobstruction and chronic airways inflammation resulting from exposure toirritants like tobacco smoke. Asthma, which remains one of the most commonchronic diseases in the world, is characterised by recurrent breathing problemsand 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, havinga novel mechanism of action involving the suppression of cough initiatingsignals originating from cough sensory nerve endings located in the lungs. Aclinical trial completed at the University of Florence, Italy in September 2011clearly demonstrated significant anti-tussive effects with nebulised VRP700 inhospitalized patients with chronic severe cough. Cough can be a very debilitating comorbidity reported by patients, especiallythose with respiratory conditions such as asthma, COPD, lung cancer,interstitial lung disease, fibrosis or lung infections. It is a neglectedsymptom which is often self-medicated. Consumer spending on OTC medications,including those for cough, grew by 10% over 2005-10, to reach GBP532 million inthe UK [source: Mintel]. However, there is very little clinical evidence forsuch OTC cough medications being really effective and it is widely recognisedby the medical community that there is a large need for more effective drugs tocontrol and prevent pathologically induced coughing.