Verona Pharma plc, the biotechnology company focused on the research, discovery and development of new therapeutic drugs for the treatment of chronic respiratory diseases, has completed a successful trial of higher doses of its lead respiratory drug, RPL554, in patients with mild asthma.
The randomized, blinded trial, with placebo control, took place in Leiden, The Netherlands, at the Centre for Human Drug Research (CHDR). The trial treated a total of 20 mild asthmatic subjects with either single doses of RPL554 or placebo administered via a nebulizer. The doses tested were two and four times the highest dose used in the safety study previously announced in September 2009, as part of the process to establish the safety and efficacy profile of RPL554.
The objective of the trial was to establish the appropriate dosage for patients with respect to efficacy and safety. The two doses of RPL554 resulted in positive bronchodilation as assessed by the standard measure of FEV1 (Forced Expiratory Volume at 1 sec). The trial was successfully completed and there were no withdrawals due to adverse effects. Of particular note was the absence of gastrointestinal symptoms related to administration of the drug.
The highest dose established at which point limited cardiovascular effects were encountered, thereby allowing the Company to set appropriate dosages for future studies. These results provide further support for RPL554 as a novel treatment for patients with respiratory diseases and further strengthen the Company’s data package for discussions with potential licensees.
Professor Michael Walker, CEO of Verona Pharma said: "The trial has run smoothly, with no major adverse events reported. These positive results underline the excellent bronchodilator effects that can be achieved with RPL554 over a range of doses. These findings were achieved with a nebulized formulation of the drug and the Company continues to work with other formulations of RPL554 in more user-friendly inhaler devices. We look forward to updating shareholders on future studies, and on progress in licensing this novel respiratory drug.”
The chemical compound RPL554 is Verona Pharma's lead drug project. It is a long acting bronchodilator/anti-inflammatory drug belonging to a class of drugs known as a mixed phosphodiesterase (PDE) 3/4 inhibitor. Verona Pharma is investigating its use for the treatment of respiratory diseases including asthma, chronic obstructive pulmonary disease (COPD) and allergic rhinitis (hay fever).