VRP.L Regulatory News (VRP)

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

Verona Pharma Commences further RPL554 Phase 2a Clinical Trial

First COPD patient dosed with RPL554 as an add-on therapy to tiotropium (Spiriva©)

Top-line data expected in 4Q 2017

22 February 2017, London - Verona Pharma plc (AIM: VRP.L) (Verona Pharma), a clinical-stage biopharmaceutical company focused on developing and commercialising innovative therapeutics for the treatment of respiratory diseases with significant unmet medical needs, today announced that the first patient has been dosed in its Phase 2a clinical trial evaluating RPL554 as an add-on therapy to tiotropium (Spiriva®), a commonly used long-acting bronchodilator, for the treatment of chronic obstructive pulmonary disease (COPD). Top-line data from the trial is expected in 4Q 2017.

Verona Pharma's product candidate, RPL554, is an inhaled, dual PDE3/PDE4 inhibitor that acts as both an anti-inflammatory agent and a bronchodilator in a single compound. Verona Pharma is currently developing RPL554 for the maintenance treatment of COPD patients and for the treatment of patients with cystic fibrosis. It is also developing RPL554 as an add-on therapy to short-acting bronchodilators and other commonly used therapies for the treatment of hospitalised patients with acute exacerbations of COPD.

The primary objective of this Phase 2a trial is to evaluate the improvement in lung function and duration of effect of RPL554 when administered as an add-on therapy to tiotropium (Spiriva®). Verona Pharma plans to enroll approximately 30 patients with moderate to severe COPD in this double-blind, placebo-controlled, three-way crossover trial. This trial will use spirometry, the measurement of lung function through the volume and/or flow of air that can be forcibly exhaled, and whole body plethysmography, a technique to measure lung volume and airway resistance, to compare RPL554 to placebo when administered with tiotropium (Spiriva®). The trial is being performed at the Medicines Evaluation Unit in Manchester, UK, by lead investigator, Professor Dave Singh.

In previous clinical trials, RPL554 has been observed to result in bronchodilatory effects when used alone or in combination with other COPD bronchodilators. These trials have shown clinically meaningful and statistically significant improvements in lung function when RPL554 is added to two commonly used bronchodilators, as compared to the improvements in lung function when either bronchodilator is administered as a single agent. RPL554 has also shown anti-inflammatory effects in a standard challenge study with COPD-like inflammation in human subjects. In these studies, RPL554 has been well tolerated.

"COPD is a chronic and debilitating respiratory disease for which there is no cure," said Dr Jan-Anders Karlsson, Verona Pharma's Chief Executive Officer. "According to the World Health Organization, COPD is the third leading cause of death globally, with 210 million people worldwide suffering from the disease. The clinical data we have announced to date supports our belief that RPL554 has the potential to be an important new treatment for COPD patients and we now continue to characterise RPL554 by studying it as an add-on therapy to tiotropium, a commonly used long-acting bronchodilator in COPD patients."

About Verona Pharma plc

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercialising innovative therapeutics for the treatment of respiratory diseases with significant unmet medical needs. 

Verona Pharma's product candidate, RPL554, is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that acts as both a bronchodilator and an anti‑inflammatory agent in a single compound. In clinical trials, treatment with RPL554 has been observed to result in statistically significant improvements in lung function as compared to placebo and has shown clinically meaningful and statistically significant improvements in lung function when added to two commonly used bronchodilators as compared to either bronchodilator administered as a single agent. Verona Pharma is developing RPL554 for the treatment of chronic obstructive pulmonary disease (COPD), cystic fibrosis, and potentially asthma.

Forward Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the timing of data releases for our Phase 2a clinical trial of RPL554 as an add-on therapy to tiotropium (Spiriva®).

These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

-Ends-

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