Verona says second PhIII for COPD drug hits the mark, plans 2023 NDA filing

UK-based biotech Verona Pharma said Tuesday morning that its drug, ensifentrine, passed its second late-stage trial for the common lung disease COPD. In August, Verona reported the drug succeeded in the first of its two Phase III trials. Now, Verona will package together the new trial data in its approval filing to the FDA, which the biotech said will come in the first half of next year. The second trial’s design is similar to the first — 500 patients got ensifentrine as their COPD maintenance treatment, 300 got placebo and all were followed for 24 weeks — but in the second trial, 400 patients were followed for an additional 24 weeks for long-term safety data.