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.
Verona’s stock $VRNA opened around 30% above its last close, jumping from under $14 to nearly $17.
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. As in the first trial, the majority of patients enrolled were already receiving some form of COPD treatment; around two-thirds were on a long-acting inhaler as background therapy, while just over 20% got inhaled corticosteroids on top of that.
Patients on Verona’s drug bested those on placebo in a breathing test that measures the ability to forcefully breathe out — the primary endpoint of the study — at week 12, and those results were consistent regardless of background medication, Verona said.
The study also met a number of secondary endpoints looking at lung function, daily COPD symptoms and overall quality of life. The only point on which ensifentrine narrowly missed statistical significance was in reducing the rate of moderate to severe COPD exacerbations. Here, patients in the treatment arm had a 36% reduction in rate of exacerbations over 24 weeks compared to placebo, good for a p-value of 0.0505.
Verona’s drug, if approved, would introduce a new class of COPD therapies, and SVP of commercial Chris Martin noted Verona believes ensifentrine “has the potential based on the data to be priced at a premium versus the current nebulised products.” Verona is also testing the drug, which is its only candidate, in mid-stage studies in cystic fibrosis and asthma.