Date: 2011-02-22
Type of information:
phase:
Announcement: results
Company: Verona Pharma (UK)
Product: RPL554
Action
mechanism: RPL554 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).
Disease: mild asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country: The Netherlands
Trial
details: The randomised, 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 RPL55.
The objective of the trial was to establish the appropriate dosage for patients with respect to efficacy and safety.
Latest
news: * On February 22, 2011, Verona Pharma has announced that it has completed a successful trial of higher doses of its lead respiratory drug, RPL554, in patients with mild asthma.
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.
