03:00 Tue 04 Apr 2017
Verona Pharma PLC - 1st Patient Dosed in Ph2a Trial for RPL554 in CF
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.
Verona Pharma Doses First Patient in Phase 2a Clinical Trial Evaluating RPL554 for Cystic Fibrosis
The Phase 2a single-dose trial is being conducted in the
The trial is being performed at the
RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3/PDE4) with anti-inflammatory as well as bronchodilatory properties, currently in development for the treatment of chronic obstructive pulmonary disease (COPD) and CF.
In pre-clinical studies, RPL554 has been observed to stimulate the CF transmembrane conductance regulator, a protein whose mutation results in dysfunctional ion channels in epithelial cells, leading to CF. Based on available data, RPL554 has the potential to enhance mucociliary clearance (reduce phlegm in the airways), reduce airway obstruction and inhibit inflammation.
In previous clinical trials in patients with COPD, 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. RPL554 has also shown anti-inflammatory effects in a standard challenge study with COPD-like inflammation in human subjects. In these previous studies, RPL554 has been well tolerated.
"Cystic fibrosis is the most common fatal inherited disease in
"Two recently approved therapies are indicated only for a subset of CF patients, and there is a need for novel, effective anti-inflammatory medications to treat the underlying inflammation in cystic fibrosis. RPL554 has a differentiated mechanism of action and pre-clinical data in cystic fibrosis combined with our positive clinical data in COPD leads us to believe it has the potential to be an important new treatment for this debilitating condition. We look forward to progressing the drug through this study and expect to announce top-line data in the first half of 2018."
For further information, please contact:
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Tel: +44 (0)20 3283 4200 |
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N+1 Singer (Nominated Adviser and |
Tel: +44 (0)20 7496 3000 |
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FTI Consulting ( |
Tel: +44 (0)20 3727 1000 |
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Tel: +1 203-682-8251 |
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Tel. +1 646-277-1282 Stephanie.Carrington@icrinc.com
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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 number of patients to be dosed in and endpoints of our Phase 2a clinical trial to evaluate RPL554 as a treatment for cystic fibrosis, the timing of top-line data from the Phase 2 clinical trial, and the potential of RPL554 to treat cystic fibrosis.
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.
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