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verona pharma plc (VNAPF) Key Developments

Verona Pharma plc Announces Encouraging Interim Results from the First Part of a 120 Subject Phase I/II Clinical Trial with RPL554

Verona Pharma plc announced encouraging interim results from the first part of a 120 subject Phase I/II clinical trial with RPL554, using a new proprietary nebulised formulation. RPL554 is a novel PDE3/4 inhibitor, which is currently in development as a nebulised treatment for acute exacerbations in COPD patients in a hospital or home-care setting. The trial is being performed at the Medicines Evaluation Unit in Manchester by lead investigator Professor Dave Singh. In the first part of this study, which was successfully completed ahead of schedule, 50 healthy volunteers were enrolled in a single ascending dose study with the new drug formulation. Five dose levels were tested with the pre-specified high dose being approximately 16 times greater than the dose tested in earlier reported clinical studies, using the previous formulation of RPL554. The results from this study showed that the drug was well tolerated across all doses and no maximum tolerated dose could be defined. Importantly, there were no changes in subjects' cardiovascular parameters and there was complete absence of nausea or vomiting at all doses. Pharmacokinetic data showed lower peak plasma levels of the drug and a plasma half-life of 11-12hr, significantly longer than that of historically published data of similar doses, using the previous formulation. This suggests that the new formulation results in a longer residence time for RPL554 in the lung and slower release into the blood stream. Pulmonary residence time is an important factor in determining duration of effect.1 These results support the potential for RPL554 to be a drug administered twice-a-day and this will be further verified in the second part of the trial, which is now being initiated. In the next part of the study, multiple ascending doses given for five consecutive days will be investigated in both healthy volunteers and patients with chronic obstructive pulmonary disease (COPD). The primary objective of this study is to further confirm safety and tolerability, as well as to investigate bronchodilation in COPD patients. In studies with the previous formulation, RPL554 generated significant bronchodilation that appeared to be at least similar in effect size to that seen with salbutamol,2 a commonly used drug in the treatment of COPD. Results from this new study are expected to be available in the second half of 2015.

Verona Pharma plc Provides Earnings Guidance for the Year Ended December 31, 2014; Provides Update on RPL554 Development Programme

Verona Pharma plc provided earnings guidance for the year ended December 31, 2014. The company expects to report a slightly lower than expected loss before tax of approximately £3.7 million 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. The company provided update on RPL554 Development Programme. The company 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.

Verona Pharma plc Announces First Patients Dosed with New Formulation of RPL554

Verona Pharma plc announced that a first cohort of healthy volunteers have been successfully dosed with a new proprietary, nebulised formulation of RPL554. These volunteers are part of a combined Phase I/II clinical trial profiling this new RPL554 formulation. The trial includes a single ascending dose study in healthy volunteers and 5 days multiple ascending dose study in both healthy volunteers and patients with COPD (chronic obstructive pulmonary disease). The primary objective of the study is to confirm safety, tolerability and bronchodilation with this new formulation. Up to 120 subjects are planned to be recruited to this study and the results are expected to be available in the second half of 2015. Verona Pharma is initially developing RPL554 as a nebulised treatment for acute exacerbations in COPD patients in a hospital or home-care setting. Phase II studies to date with the drug, a novel PDE3/4 inhibitor, have been conducted in over 100 subjects. Results collectively show that the drug is a very potent bronchodilator with the ability to illicit a unique anti-inflammatory response. At the doses tested, RPL554 had a benign side effect profile, which compared favourably with existing standard treatments. The original nebulised formulation of the drug used in these initial studies was devised to provide proof-of-concept data, before developing a new formulation suitable for commercial scale-up. The new proprietary formulation of RPL554 has demonstrated very attractive properties, in addition to being viable for commercial scale-up. In pre-clinical testing, inhalation of this new formulation was better tolerated, producing significantly less irritation than the one used previously. It is expected that this will result in a significantly improved therapeutic index in patients, implying that they should be able to inhale higher doses over a shorter time interval, improving convenience and potentially compliance.

Verona Pharma plc Presents at 7th annual Biotech Showcase Conference 2015, Jan-13-2015 04:30 PM

Verona Pharma plc Presents at 7th annual Biotech Showcase Conference 2015, Jan-13-2015 04:30 PM. Venue: Parc 55 Wyndham San, Francisco - Union Square, San Francisco, CA 94102, United States. Speakers: Sven Jan-Anders Karlsson, Chief Executive Officer and Executive Director.

Verona Pharma plc Appoints Kenneth Newman as Chief Medical Officer, Effective January 1, 2015; Announces Incorporation of Verona Pharma, Inc

Verona Pharma plc announced the appointment of Kenneth Newman, M.D., M.B.A. to the newly created position of Chief Medical Officer, with effective from 1 January 2015. Dr. Newman will be based in the US and provide his expertise to support the company's global activities. Dr. Newman is an experienced pharmaceutical and biotechnology industry executive with extensive leadership experience in clinical development, including a number of orally inhaled drugs for the treatment of respiratory disease. Dr. Newman will join Verona Pharma from Mesoblast Inc, where he was Chief Development Officer and Head of Global Clinical Development. The appointment and the creation of the US affiliate reflects the continuing focus of Verona Pharma on advancing the clinical development and commercialization of its lead pipeline drug, RPL554, a first-in-class PDE3/PDE4 inhibitor currently in phase II development for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. The company also announced the incorporation of its fully owned subsidiary, Verona Pharma Inc.


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