Verona Pharma Release: Interim Results For The Six Months Ended 30 June 2015
8 September 2015, Cardiff – Verona Pharma plc (AIM: VRP), the drug development company focused on first-in-class medicines to treat respiratory diseases, today announces its interim results for the six months ended 30 June 2015.
OPERATIONAL HIGHLIGHTS
• Successfully completed dosing of healthy volunteers in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies with our new, commercially scalable, proprietary nebulized formulation of RPL554.
o The formulation was well tolerated with subjects dosed with up to 16 times the dose of RPL554 previously shown to produce significant bronchodilation without a maximum tolerated dose being reached.
o Successful completion of SAD part of trial demonstrated no effect on cardio vascular parameters and no nausea or vomiting observed at any dose.
• Commenced a MAD study of RPL554 in June 2015 in up to 30 chronic obstructive pulmonary disease (COPD) patients to further confirm the safety and tolerability seen in earlier parts of the trial, with this new formulation.
o Data are expected from the combined SAD/MAD study in healthy subjects and COPD patients in early Q4 2015.
• Initiated a phase 2a dose-finding trial in asthma patients with new proprietary formulation of RPL554, to explore a dose-response relationship in this setting.
o Headline data from this study are anticipated in Q1 2016.
FINANCIAL HIGHLIGHTS
• Loss after tax for the period of £3.69 million (2014: £1.39 million) or 0.37 pence (2014: 0.19 pence) per ordinary share, reflecting accelerated R&D activities.
• Net cash outflows from operating activities during the six month period of £3.92m (2014: £1.47m), with cash and cash equivalents as at 30 June 2015 of £6.09 million (2014: £12.10 million).
POST PERIOD AND OTHER EVENTS
• Completed dosing with new nebulized formulation in MAD study in COPD patients with data expected in early Q4 2015.
• Appointed Ken Cunningham MD and Anders Ullman MD PhD as Non-Executive Directors to the Board effective 10 September 2015 (as announced separately today). Both are recognised leaders in the pharmaceutical and biotechnology industry and have particular clinical development expertise in the area of respiratory drug development.
• The Company undertook a secondary listing of its shares on the Xetra Exchange in Frankfurt to increase awareness of the Company and to facilitate trading in its shares in Continental Europe.
Dr. Jan-Anders Karlsson, CEO of Verona Pharma commented: “In the first half of 2015 we have continued to make good progress with our lead drug candidate, RPL554. In particular, initial results from studies in healthy volunteers using our new more robust formulation of the drug have been extremely encouraging. These data bode well for the outcome of our ongoing phase 2a multiple ascending dose study with the drug in COPD patients, where we expect to announce results in early Q4 2015. During the period we also initiated a phase 2a trial of RPL554 in asthma patients to explore a dose-response relationship in this setting and will report results early next year. Positive data in these studies will encourage us to move into phase 2b studies. Further studies in cystic fibrosis with RPL554 are planned for 2016. Additionally we continue to seek to develop the Company by searching for suitable products to enhance our pipeline.”
For further information please contact:
Verona Pharma plc
Tel: +44 (0)20 7863 3300
Jan-Anders Karlsson, CEO
Biresh Roy, CFO
N+1 Singer
Tel: +44 (0)20 7496 3000
Aubrey Powell / Jen Boorer
FTI Consulting
Tel: +44 (0)20 3727 1000
Simon Conway / Stephanie Cuthbert / Natalie Garland-Collins
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.
Bronchodilating therapy is considered 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.1 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.
Help employers find you! Check out all the jobs and post your resume.
OPERATIONAL HIGHLIGHTS
• Successfully completed dosing of healthy volunteers in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies with our new, commercially scalable, proprietary nebulized formulation of RPL554.
o The formulation was well tolerated with subjects dosed with up to 16 times the dose of RPL554 previously shown to produce significant bronchodilation without a maximum tolerated dose being reached.
o Successful completion of SAD part of trial demonstrated no effect on cardio vascular parameters and no nausea or vomiting observed at any dose.
• Commenced a MAD study of RPL554 in June 2015 in up to 30 chronic obstructive pulmonary disease (COPD) patients to further confirm the safety and tolerability seen in earlier parts of the trial, with this new formulation.
o Data are expected from the combined SAD/MAD study in healthy subjects and COPD patients in early Q4 2015.
• Initiated a phase 2a dose-finding trial in asthma patients with new proprietary formulation of RPL554, to explore a dose-response relationship in this setting.
o Headline data from this study are anticipated in Q1 2016.
FINANCIAL HIGHLIGHTS
• Loss after tax for the period of £3.69 million (2014: £1.39 million) or 0.37 pence (2014: 0.19 pence) per ordinary share, reflecting accelerated R&D activities.
• Net cash outflows from operating activities during the six month period of £3.92m (2014: £1.47m), with cash and cash equivalents as at 30 June 2015 of £6.09 million (2014: £12.10 million).
POST PERIOD AND OTHER EVENTS
• Completed dosing with new nebulized formulation in MAD study in COPD patients with data expected in early Q4 2015.
• Appointed Ken Cunningham MD and Anders Ullman MD PhD as Non-Executive Directors to the Board effective 10 September 2015 (as announced separately today). Both are recognised leaders in the pharmaceutical and biotechnology industry and have particular clinical development expertise in the area of respiratory drug development.
• The Company undertook a secondary listing of its shares on the Xetra Exchange in Frankfurt to increase awareness of the Company and to facilitate trading in its shares in Continental Europe.
Dr. Jan-Anders Karlsson, CEO of Verona Pharma commented: “In the first half of 2015 we have continued to make good progress with our lead drug candidate, RPL554. In particular, initial results from studies in healthy volunteers using our new more robust formulation of the drug have been extremely encouraging. These data bode well for the outcome of our ongoing phase 2a multiple ascending dose study with the drug in COPD patients, where we expect to announce results in early Q4 2015. During the period we also initiated a phase 2a trial of RPL554 in asthma patients to explore a dose-response relationship in this setting and will report results early next year. Positive data in these studies will encourage us to move into phase 2b studies. Further studies in cystic fibrosis with RPL554 are planned for 2016. Additionally we continue to seek to develop the Company by searching for suitable products to enhance our pipeline.”
For further information please contact:
Verona Pharma plc
Tel: +44 (0)20 7863 3300
Jan-Anders Karlsson, CEO
Biresh Roy, CFO
N+1 Singer
Tel: +44 (0)20 7496 3000
Aubrey Powell / Jen Boorer
FTI Consulting
Tel: +44 (0)20 3727 1000
Simon Conway / Stephanie Cuthbert / Natalie Garland-Collins
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.
Bronchodilating therapy is considered 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.1 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.
Help employers find you! Check out all the jobs and post your resume.