Verona Pharma Reports Encouraging Top-Line Data from Three-Day Phase 2 Trial

Verona Pharma (AIM:VRP) (Nasdaq:VRNA) a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces top-line data from its three-day Phase 2 clinical pharmacology trial evaluating the effect of two different doses (1.5 mg and 6.0 mg; twice daily) of nebulized ensifentrine (RPL554) when used on top of an inhaled long-acting muscarinic antagonist/long-acting beta2 agonist (“LAMA/LABA”), tiotropium/olodaterol (Stiolto^®Respimat^®).

As quoted in the press release:

“Achieving additional bronchodilator response of this magnitude in COPD patients that have previously been considered to be maximally bronchodilated on background dual or triple therapy in a short, three-day study is clinically meaningful and unprecedented,” commented Dave Singh, M.D., Professor of Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit, University of Manchester. “The statistically significant reduction observed in residual volume for the ensifentrine 1.5 mg dose at certain time points, which is closely related to dyspnea or breathlessness, highlights the potential for ensifentrine to provide symptomatic improvement for patients with this progressive and debilitating disease. I look forward to seeing data from longer-term studies evaluating the bronchodilator and anti-inflammatory activity of this unique mechanism of action.”

“Having demonstrated in previous studies the potential of ensifentrine to deliver benefits to patients on no or single bronchodilator therapy, we believe that this short study continues to support our view that ensifentrine may also be of benefit to more severe COPD patients on dual and triple therapy, for whom there are few other treatment options,” said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. “While we are disappointed that this exploratory Phase 2 study did not achieve statistical significance for its primary endpoint, these data give us clarity on the design, including dose and background therapy, for future long-term studies. We now have the opportunity to also include patients on dual and triple therapy, with the goal of further evaluating ensifentrine’s potential to produce sustained bronchodilation and anti-inflammatory effect in this large number of symptomatic COPD patients.”

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