VRP Verona Pharma Plc

Verona Pharma plc

("Verona Pharma" or the "Company")

2015 in review – A successful year with significant progress

21 March 2016, Cardiff – Verona Pharma plc (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.

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 Jan-Anders Karlsson 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 on the 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.  Verona Pharma therefore continues to be involved in business development discussions around the RPL554 programme.“

2015 Highlights

• 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 Anders Ullman and Dr Ken Cunningham, two physicians highly experienced in the development of respiratory medicines

• Loss before tax expected at approximately £8.9m for the year ended 31 December 2015 (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 31 December 2015 was GBP 3.5 million (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.

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 American Thoracic Society meeting in San Francisco in mid May 2016.

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 $1 billion in 2014 in the US.²  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 Anders Ullman, who joined the Board in September 2015, was previously Chief Medical Officer at Nycomed (now Takeda) and was responsible for the development and approval of roflumilast (Daxas®) 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 Lancet in February 2015. 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 Ken Cunningham, 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 Europe and Japan for the treatment of asthma and licensed to Mundipharma. Ken was also chairman of Prosonix, an inhalation development company, purchased by Circassia in 2015.

By adding Dr Ullman and Dr Cunningham to the Board we have significantly expanded the expertise on the Board both in terms of respiratory medicine and significant transaction experience.

References

¹ Results were reported in a press release, 15 March 2016 (post period end)

² IMS Consulting Group market research 2014

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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 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. 

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.  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 UK Cystic Fibrosis Trust.