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Verona Pharma lung disease therapy fails in mid-stage study

Verona Pharma PLC's shares fell after it disclosed that the mid-stage study of nebulized ensifentrine in a common lung disease failed to meet its main goal.

U.K.-based Verona's shares were down 33.66% to 68.99 pence as of 7:13 a.m. ET on Jan. 14.

The biopharmaceutical company was assessing the effect of nebulized ensifentrine — also known as RPL554, in 1.5 milligram and 6.0 milligram doses — when used in addition to Boehringer Ingelheim Pharmaceuticals Inc.'s Stiolto Respimat inhaler in patients with moderate to severe chronic obstructive pulmonary disease, or COPD, a life-threatening respiratory disease with no available cure. About 384 million people are affected by the disease worldwide and the World Health Organization expects COPD to become the third leading cause of death globally by 2030.

Based on the topline results of the phase 2 clinical trial, the main goal of peak forced expiratory volume in 1 second, or FEV1 — a lung function index used for early detection of COPD — did not achieve statistical significance on the third day of therapy.

However, the ensifentrine 1.5 milligram morning dose improved peak FEV1, by 46 milliliters, compared to placebo — an improvement that was maintained throughout the 24-hour period as measured on the third day.

Peak FEV1 after evening dose on the third day showed statistically significant improvement, compared to placebo, with the 1.5 milligram dose showing a 130 milliliter improvement and the 6.0 milligram dose showing an 81 milliliter improvement. The higher dosage did not result in greater improvement in lung function.

Ensifentrine was well received at both doses with side effects consistent with those observed in previous studies.

Verona Pharma is conducting a phase 2 study to evaluate a dry powder inhaler formulation of ensifentrine for the maintenance treatment of COPD, with plans to assess the drug in a metered-dose inhaler formulation. The company is also evaluating nebulized ensifentrine for treating cystic fibrosis, or mucus buildup in the lungs, and asthma.

"Whilst the lack of statistical significance could dominate the headlines, we believe the incremental plus 46 milliliters FEV1 benefit with 1.5 milligram morning dose of ensifentrine on top of double, or even triple, standard of care is promising," Jefferies analyst Peter Welford wrote in a note to clients.