Verona Pharma’s VRP700 Did Not Meet Primary Goals In Phase 2a Trial

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Verona Pharma Reports Phase 2a Headline Results For VRP700

Verona Pharma plc (AIM: VRP), the drug development company focused on “first-in-class” medicines to treat respiratory diseases, today announces that the Phase IIa clinical trial, to evaluate the efficacy of a single dose of VRP700 as a novel treatment for chronic severe cough in patients with idiopathic pulmonary fibrosis (IPF) did not meet the primary endpoint of a statistically significant reduction in cough frequency when compared to placebo.

This placebo-controlled, cross-over exploratory study was conducted in 20 IPF patients who received, as part of the protocol, a single inhaled dose of either 100 mg VRP700 or placebo. It follows the successful outcome of a single centre pilot study in which an inhaled dose of VRP700 effectively inhibited coughing in a smaller group of patients with interstitial lung disease (ILD).

Verona Pharma CEO, Dr. Jan-Anders Karlsson, commented: “These data are clearly disappointing and did not meet our expectations given the marked inhibition of coughing observed in a previous clinical trial with patients administered VRP700, albeit with a different underlying disease, ILD. It is possible that VRP700 works better in such patients or that more frequent dosing, for a longer time period, may be required to effectively suppress coughing in IPF patients. While we will not undertake any further in-house development of VRP700, we will comprehensively review the data from this study and explore opportunities to realise further value from this asset.

“In the meantime - and as outlined at the time of our recent fundraising - we will continue to focus on the development of our novel lead drug, RPL554. This inhaled, first-in-class, PDE3/PDE4 inhibitor has both bronchodilator and anti-inflammatory properties and is initially being developed as a nebulized treatment for acute exacerbations of COPD. The next set of clinical data for RPL554 is expected in early 2015.”

For further information please contact:

Verona Pharma plc
Tel: 020 7863 3300
Jan-Anders Karlsson, CEO
Richard Bungay CFO

WH Ireland Limited
Tel: 020 7220 1666
Chris Fielding
Nick Field

FTI Consulting
Tel: 020 3727 1000
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].

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