Date: 2015-06-15
Type of information: Treatment of the first patient
phase: 2a
Announcement: treatment of the first patient
Company: Verona Pharma (UK)
Product: RPL554
Action
mechanism: phosphodiesterase 3/4 inhibitor. 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: asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial details:
Latest
news: * On June 11, 2015, Verona Pharma announced that the first patients have been dosed with RPL554 in a Phase 2a dose-finding trial in asthma patients using the Company’s new proprietary nebulised formulation. RPL554 is a novel inhaled PDE3/PDE4 inhibitor, currently in development as a nebulised treatment for acute exacerbations in chronic obstructive pulmonary disorder (COPD) patients in a hospital or home-care setting.
The study is being carried out in asthmatics as typically a dose response relationship to bronchodilators can be more accurately established in this group of patients, compared to COPD patients. In this trial, up to 30 patients with mild to moderate chronic asthma will each receive single doses of nebulised RPL554, from the very low dose to the highest dose previously tested in the Phase 1b single ascending and multiple ascending dose (SAD and MAD) studies of the same drug in healthy subjects. In this double-blind, placebo-controlled, crossover study each patient will also receive two different doses of nebulised salbutamol, a commonly used bronchodilator in these patients, and placebo. The primary objective of the trial is to establish the bronchodilator effect and duration of action of RPL554 in asthma patients. The study is being performed at Celerion (Belfast, Ireland) and Skane University Hospital (Lund, Sweden).
Phase 1b results in SAD and MAD studies of nebulised RPL554 with this new formulation in healthy volunteers, have demonstrated that the drug is well tolerated in doses up to 16 times larger than those previously demonstrated to produce bronchodilation using the prior formulation. Given that this new formulation is better tolerated and higher doses can be administered, this latest trial is likely to provide useful data for further development work on RPL554 and also its potential as a future treatment for asthma sufferers.
