Verona Pharma has announced positive data from a Phase 2a study of RPL554, an inhaled PDE3/PDE4 inhibitor for the treatment of acute exacerbations in COPD patients. According to the company, asthma patients who received the nebulized RPL554 experienced no serious adverse events over the entire dose range of 0.4 to 24 mg and demonstrated a maximum bronchodilator effect similar to that produced by a 7.5 mg dose of salbutamol (albuterol).
In September 2015, the company announced that an ascending dose study of its new formulation of RPL554 showed that the inhalation suspension was well tolerated. This new study investigated lower doses than studies of the previous formulation and found that all doses were significantly more effective than placebo, with linear pharmacokinetics across the entire dose range.
Verona Pharma CEO Jan-Anders Karlsson commented, “We are very excited by the results from our dose-finding study for RPL554. It is very pleasing that the maximum bronchodilator effect of RPL554 is comparable to that seen with the highest dose of salbutamol used in the study – a dose equivalent to the highest dose of salbutamol used to treat acute exacerbations of COPD in the emergency department – it is noteworthy that this was achieved with fewer adverse events. The data generated in this study emphasises its pronounced bronchodilator effect, and combined with its unique anti-inflammatory effects, we continue to believe that RPL554 could be an important, and much needed, new treatment option, either alone or as an add-on to existing drugs, for patients with COPD.”
According to the company, it plans to begin a Phase 2b trial in early 2017.
Read the Verona Pharma press release.