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Verona Pharma: Clinical Data Presented at ERS



9/10/2013 9:26:01 AM

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London, UK, 10 September 2013 – Verona Pharma plc (AIM: VRP), the drug development company focused on “first-in-class” medicines to treat respiratory diseases, announces that two presentations discussing results from successfully completed RPL554 clinical trials were presented the European Respiratory Society (ERS) Annual Congress in Barcelona, Spain 7-11 September 2013. The abstracts for these presentations are reproduced below.

The ERS Annual Congress is the largest respiratory meeting in the world, with delegates attending from more than 100 countries. All abstracts and details on timings can be accessed through the ERS website: http://www.erscongress2013.org.

Poster Number:

Title: P708 Bronchodilator effect of a novel inhaled dual PDE3/4 inhibitor, RPL554, in mild allergic asthma & rhinitis

Authors: Z. Diamant, L. Franciosi, N. Morelli, R. Zuiker, I. Kamerling, M. de Kam, K. Burggraaf, A. Cohen, M. Walker, C. Page (Lund, Sweden; Groningen, Leiden, Netherlands; London, United Kingdom; Vancouver, Canada)

Abstract:

Background: RPL554 is a novel inhaled dual phosphodiesterase (PDE) 3 & 4 inhibitor with long-acting bronchodilator & anti-inflammatory effects in preclinical models.

Aims and Objectives: To evaluate RPL554 safety & efficacy in mild allergic asthma & rhinitis.

Methods: In 2 randomised, double-blind, placebo-controlled, crossover trials, 10 mild allergic asthmatics (M; 20-50y; FEV1: 82-112%prd; PC20Mch: 0.07-1.49mg/mL; SABA prn only) and 10 allergic rhinitics (M; 19-44y; 6 with co-existing asthma; FEV1: 83-128%prd) were studied. In asthmatics, a methacholine challenge (PC20Mch) was done 1h from nebulisation start to assess bronchoprotection. Using a jet nebuliser, RPL554 0.018mg/kg was inhaled 10min via an oro-nasal mask. Standard safety & pharmacokinetic measurements were at predetermined times from nebulisation start with spirometry at pre-dose & regularly for 24h. Bronchodilation was assessed by FEV1 changes.

Results: RPL554 was well-tolerated. Adverse events were mild, transient & generally of equal frequency in RPL554 & placebo groups with no significant changes in heart rate or systemic blood pressure noted. In asthmatics, RPL554 produced rapid, sustained bronchodilation, with a mean maximal FEV1 increase of 520mL (95%CI: 320-720mL; p<0.0001) or 15% increase from baseline vs. placebo. It also increased PC20MCh by mean 1.5 doubling doses (95%CI: 0.63– 2.3; p=0.004). In rhinitics, a maximal bronchodilator response occurred between 30min & 3h with a mean maximal FEV1 increase of 300mL or 7.5% increase (95%CI: 90-310mL; p=0.004).

Conclusions: RPL554 produced safe, rapid, long-lasting bronchodilation in mild allergic asthmatics & rhinitics, with bronchoprotection in asthmatics.

Presentation Number:

Title: 1969 LATE BREAKING ABSTRACT: Anti-inflammatory effect of a novel inhaled dual PDE3/4 inhibitor RPL554 in man, a unique “first-in-class” drug for the treatment of COPD & asthma

Authors: D. Singh, F. Reid, L. Franciosi, M. Walker, C. Page (Manchester, London, United Kingdom; Vancouver, Canada)

Abstract: Background: Current bronchodilators have limited efficacy in severe COPD & asthma & the neutrophilic inflammation is not well treated. RPL554 is a novel, well tolerated dual PDE 3/4 inhibitor with significant bronchodilator properties in COPD & asthma, bronchoprotective effects in asthmatics & is anti-inflammatory pre-clinically.

Aim: To evaluate the effect of RPL554 on inhaled lipopolysaccharide (LPS)-induced neutrophilia in sputum.

Methods: In a randomised, double-blind, placebo (PBO)-controlled crossover study in 21 healthy subjects, RPL554 (0.018mg/kg)was inhaled using a jet nebuliser via an oro-nasal mask o.d for 6 days. On day 6 an inhaled LPS challenge was performed 1h post RPL554 or PBO using a Mefar dosimeter. Sputum was induced 6 & 24h post-LPS & cells/g sputum calculated.

Results: RPL554 statistically significantly reduced total & individual cells, 6h post LPS vs PBO (Table 1). RPL554 was well-tolerated with AE’s being generally mild, transient & not different from PBO. RPL554’s PK properties were reproducible over 6 days.

Conclusions: RPL554 produced significant airway anti-inflammatory effects, including reducing neutrophil infiltration & is the first drug demonstrating bronchodilator & anti-inflammatory properties in one molecule. RPL554 is thus a promising “bifunctional” first in class treatment for patients with COPD or asthma and not well controlled on existing treatment.

For further information please contact:

Verona Pharma plc Tel: 020 7863 3300

Clive Page, Chairman

Jan-Anders Karlsson, CEO

Richard Bungay, CFO

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 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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