Verona Pharma has announce that data from the third part of single ascending dose (SAD)/multiple ascending dose (MAD) trial of nebulized RPL554 in COPD patients show that the formulation was well tolerated at all doses with no serious adverse events and that patients using RPL554 experienced “pronounced improvement in lung function.” Verona reported results from earlier portions of the study in March 2015.
According the the company, the suspension formulation of RPL554 used in this study produced greater bronchodilation than a proof of concept formulation used in earlier studies, with peak FEV1 increase compared to placebo ranging from 199-257ml. Verona also said that the new formulation is more stable than the original formulation.
Verona Pharma CEO Jan-Anders Karlsson commented, “We are excited by the robust and consistent results arising from our SAD/MAD study of RPL554 in both healthy volunteers and now, stable COPD patients with moderate disease severity. The data demonstrates that, as designed, the new commercially scalable, suspension formulation is well tolerated and has allowed us to extend the dose range and the duration of bronchodilation effect that can be produced in COPD patients. We will now fully analyze the data from this trial. While we need to discuss these results and confirm our further development plans for the drug with the appropriate regulatory authorities, we currently expect to begin Phase 2b studies in the second half of 2016.”
Read the Verona Pharma press release.
