Solid progress leads to acceleration of RPL554 trials
3 March 2015, Cardiff – Verona Pharma plc (AIM: VRP.L), the drug development company focused on first-in-class medicines to treat respiratory diseases, today announces a trading update for the year ended 31 December 2014, as well as an update on the Company’s development programme for its lead drug, RPL554. It is expected that financial results for the year ended 31 December 2014 will be published during the first week of May.
The closing cash position at year end was £9.97m, in line with market expectations. The Board continues to believe that this is sufficient capital to progress RPL554 to the start of Phase IIb clinical trials in 2016.
The Company expects to report a slightly lower than expected loss before tax of approximately £3.7m for the year ended 31 December 2014. The loss reflects slightly lower than expected expenditure on R&D and slightly lower expenditure than expected on general and administrative costs. Costs associated with expansion of the senior management team and board only incurred towards the end of the year.
Update on RPL554 Development Programme
Verona Pharma is fully focused on developing RPL554 and in January this year announced that the first subjects had successfully been dosed in the initial clinical trial with its new proprietary and commercially scalable nebulized formulation of RPL554. The initial clinical trials are designed to prepare RPL554 for the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD).
The Board remains excited by the prospects for RPL554 as it advances further into development in 2015. Following a thorough review of the planned development and associated expenditure for RPL554, the Board has concluded that it is now timely to accelerate the work on the drug to progress to the start of phase IIb clinical trials in 2016. Therefore, gross R&D expense to be incurred in 2015 will be substantially greater than previously expected. The higher R&D spending in 2015 essentially results from moving work forward from 2016 into the current year.
The overall expenditures for 2015 are currently expected to be approximately a third higher than previously anticipated, before taking into account the prospective benefit of R&D tax credits. The Company will continue to apply for these and reasonably expects such recovery to rise proportionately with the increased R&D expenditure and be realised in the subsequent accounting period.
In Q4 2014, the Board was strengthened by the addition of a highly experienced new Chairman and a full-time Chief Financial Officer with significant transaction experience. In addition, senior management was augmented at the beginning of this year with the appointment of an experienced Chief Medical Officer, a pulmonologist with deep respiratory expertise.
Dr Jan-Anders Karlsson, Chief Executive Officer of Verona Pharma, said:
“We plan to start a number of additional studies with the new proprietary formulation of RPL554 this year. The aim of these studies is to confirm its benign safety profile while further demonstrating the pronounced bronchodilator activity in healthy subjects, asthmatics and COPD patients of this unique first-in-class drug. Results from these trials will be reported as they occur on an ongoing basis during the year. We will be able to provide the first update from the on-going study in the Medicines Evaluation Unit, Manchester, at the beginning of the second quarter, which is earlier than expected.”
-Ends-
For further information please contact:
Verona Pharma plc
Tel: +44 (0) 20 3283 4200
Jan-Anders Karlsson
Chief Executive Officer
N+1 Singer
Tel: +44 (0)20 7496 3000
Aubrey Powell / Jen Boorer
FTI Consulting
Tel: +44 (0)20 3727 1000
Julia Phillips / Simon Conway
Notes to Editors
About Verona Pharma plc
Verona Pharma plc is a UK-based clinical stage biopharmaceutical company focused on the development of innovative prescription medicines to treat respiratory diseases with significant unmet medical needs, such as chronic obstructive pulmonary disease (COPD), asthma and cystic fibrosis.
Verona Pharma’s lead drug, RPL554, is a first-in-class drug currently in Phase II trials as a nebulised treatment for acute exacerbations of COPD in the hospital setting. The drug is a dual phosphodiesterase (PDE) 3/4 inhibitor and therefore has both bronchodilator and anti-inflammatory effects, which are essential to the improvement of patients with COPD and asthma.
Verona Pharma is also building a broader portfolio of RPL554-containing products to maximise its benefit to patients and its value. This includes the very significant markets for COPD and asthma maintenance therapy. The Company is also exploring the potential of the drug in different diseases, such as cystic fibrosis, where it is in pre-clinical testing and has recently received a Venture and Innovation Award from the Cystic Fibrosis Trust.
About Chronic Obstructive Pulmonary Disease (COPD)
Sixty-five million people worldwide suffer from moderate to severe COPD and the World Health Organisation (WHO) expects COPD to be the 3rd leading cause of death globally by 2020. It is the only major chronic disease with increasing mortality. Currently available drugs are aimed at long-term maintenance therapy, with the market dominated by large pharma. Despite the wide availability of these therapies, COPD patients suffer acute periods of worsening symptoms (exacerbations), which cause, in the US alone, some 1.5 million A&E visits, 726,000 hospitalisations and 120,000 deaths per annum.
IMS Consulting Group considers bronchodilating therapy to be the standard of care, and agents can be administered via handheld devices such as metered dose inhaler (MDI), dry powder inhaler (DPI) and by nebulisers. The nebulised bronchodilator market was worth about $1 billion in 2014 in the US. RPL554 is being developed by Verona Pharma as an add-on therapy to the “Standard of Care” with the objectives of providing rapid and pronounced improvement in lung function, reduced symptoms and both shortened duration of hospital stays and reduced re-admission rates 30 days after discharge from hospital. Studies to date on RPL554 have demonstrated that it has a strongly differentiated 3-way mode of action, being: (1) bronchodilation (the relaxation of smooth muscle in the airway); (2) anti-inflammatory effects on cells and (3) ion channel activation in epithelial cells, with increased mucociliary clearance of the airway.
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