Verona Pharma has announced that a Phase 2b study of its RPL554 inhaled PDE3/PDE4 inhibitor met its primary endpoint, demonstrating significant improvement in FEV1 compared to placebo at 4 weeks in patients with moderate-to-severe COPD for all 4 doses tested. The study also met secondary endpoints, with significant improvements in 12-hour average FEV1, respiratory symptoms, and quality of life.
The 4-week study enrolled 403 patients who received twice-daily nebulized RPL554 at doses of 0.75 mg, 1.5 mg, 3.0 mg or 6.0 mg or placebo and was unable to determine a minimum effective dose. According to Verona, peak bronchodilation was produced at the first doses and was sustained over the 4 weeks of dosing, with absolute changes from baseline of >200mL.
Lead investigator Dave Singh, Professor of Clinical Pharmacology and Respiratory Medicine at the University of Manchester, said, “The results from this relatively large and well-designed study are very encouraging and clinically meaningful. The large and sustained improvement in lung function and reduction in COPD symptoms, including reduction in breathlessness, are particularly noteworthy. When coupled with the drug’s unique mechanism of action, these data underline the potential for RPL554 as a new complementary treatment for patients with this progressive and debilitating disease, where there remains a high unmet medical need.’’
Verona Pharma CEO Jan-Anders Karlsson commented, “These results are very encouraging and strongly support the progression of RPL554 into later stage development as an inhaled treatment for COPD patients. The future clinical development and the positioning of this novel treatment will be informed by these data as well as by the outcome of the clinical study as an add-on to established combination therapies planned to start this year, and our ongoing market research.”
In March 2016, Verona announced positive results from a Phase 2a dose-finding study of RPL554 in asthma patients. RPL554 is also in Phase 2 development for the treatment of cystic fibrosis.
Read the Verona Pharma press release.
