03:00 Mon 21 Mar 2016
VERONA PHARMA PLC - Verona Pharma: 2015 in review
("" or the "Company")
2015 in review – A successful year with significant progress
– (AIM: VRP.L), the drug development company focused on first-in-class medicines to treat respiratory diseases, today provides a summary review of its 2015 performance., Cardiff
Primary goals in 2015 were centred around initiating and completing a series of clinical trials on its drug candidate, RPL554, using the Company’s new proprietary nebulised suspension formulation. RPL554 is a novel inhaled PDE3/PDE4 inhibitor with both bronchodilator and anti-inflammatory properties, currently in development as a nebulised treatment for acute exacerbations in chronic obstructive pulmonary disease (COPD) patients in a hospital or home-care setting.
Commenting on progress, CEO said:
“At the time of our 2014 fund raise we laid out our plans for further development of RPL554, initially to address severe COPD. Based onthe strength of the emerging clinical data, we decided in early 2015 to accelerate this development plan.
“To date almost 300 subjects have been included in clinical trials with RPL554. Collectively these data consistently highlight that the drug is an effective bronchodilator and has a broad anti-inflammatory profile. Importantly, it is well-tolerated over a wide dose range and adverse events are similar to those in subjects treated with placebo.
““Having made marked clinical progress with RPL554, we are currently considering all options for further funding of our development programmes. As part of this process, and as previously stated, the Company recognises that the right commercial partner could bring significant value to the development of RPL554 for chronic maintenance treatment in COPD and perhaps asthma. therefore continues to be involved in business development discussions around the RPL554 programme.
2015 Highlights
Marked Clinical Progress with RPL554
During 2015 the Company made excellent progress in developing the new proprietary nebulised suspension formulation of RPL554. The clinical studies which completed in 2015, the results of which have since been reported, exposed this new formulation to healthy volunteers, and to COPD and asthma patients. Results consistently showed that the product has a pharmacokinetic profile which permits twice-daily dosing, and that it elicits a profound dose dependant bronchodilator response. There was also an absence of serious adverse events. Additionally, the clinical segment of a Phase II study examining nebulised RPL554 as an add-on treatment to standard bronchodilators such as ipratropium and salbutamol was also completed during 2015 and we expect top line data to be available in Q2 2016. Three presentations of some of the results of these studies will be made at the meeting in in mid .
The Company is highly encouraged by the results demonstrated with this new formulation of RPL554 and is preparing plans to progress this formulation into a Phase IIb clinical programme to investigate treatment of acute exacerbations in COPD. The nebuliser bronchodilator market was estimated to be worth about in 2014 in the US. The Company is also planning additional pre-clinical and clinical work in Cystic Fibrosis and potentially other respiratory conditions.
Board of Directors Further Strengthened During the Year
The Company also significantly strengthened the Board of Directors during the year. Dr , who joined the Board in , was previously Chief Medical Officer at Nycomed (now Takeda) and was responsible for the development and approval of roflumilast () which was approved for the treatment of COPD. He also oversaw the initiation of a post-approval Phase IV study (the REACT study) which was published in the in . This study demonstrated that treatment with the PDE4 Inhibitor roflumilast leads to a 24% reduction in severe COPD exacerbations even in the presence of “double“ or “triple“ therapy. Subsequently AstraZeneca purchased the global commercial rights to roflumilast from Takeda.
Dr , who also joined the Board in September, was the CEO of Arakis, a respiratory company sold to Sosei. He was also a former CEO of Skyepharma plc, which developed the orally inhaled drug flutiform®, which is approved in and for the treatment of asthma and licensed to . Ken was also chairman of Prosonix, an inhalation development company, purchased by Circassia in 2015.
By adding and to the Board we have significantly expanded the expertise on the Board both in terms of respiratory medicine and significant transaction experience.
References
Results were reported in a press release, (post period end)1
market research 20142
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About
is a -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.
lead drug, RPL554, is a first-in-class drug currently in Phase 2 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.
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. In addition, the Company is exploring the potential of the drug in different diseases, such as cystic fibrosis, where it is in pre-clinical testing and has received a Venture and Innovation Award from the .
-- Initiation and successful completion of a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Phase I/II trial in 112 healthy volunteers and COPD patients using the new suspension formulation of RPL554 -- Initiation and successful completion of a dose-finding Phase IIa study in 29 patients with chronic persistent asthma in comparison to salbutamol and placebo1 -- Initiation and end of clinical stage of Phase IIa study in 30 COPD patients in which RPL554 was administered on top of standard of care bronchodilators; results expected in Q2 2016 -- Board of Directors strengthened by appointment of Dr and Dr , two physicians highly experienced in the development of respiratory medicines -- Loss before tax expected at approximately £8.9m for the year ended 31 (2014:£2.8m), broadly in line with market expectations, reflecting tight cost control despite the planned increase in R&D spend, especially on clinical studies -- Cash balance (unaudited) at was (2014: £10.0); Clinical activity is expected to be at a lower level in 2016 than in 2015 as the Company plans the next tranche of clinical studies. Thus the Board believes the Company has sufficient capital to progress RPL554 to the start of Phase IIb clinical trials, earmarked to begin around the end of 2016.Anders Ullman Ken Cunningham December 2015 31 December 2015 GBP 3.5 million
Tel: +44 (0) 20 7863 3300 , CEO N+1 Singer Tel: +44 (0)20 7496 3000 / FTI Consulting Tel: +44 (0)20 3727 1000 /Verona Pharma plc Jan-Anders Karlsson Aubrey Powell Jen Boorer Simon Conway Julia Phillips
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