Verona Pharma (NASDAQ:VRNA) announces the results from a three-day Phase 2 pharmacology study evaluating two doses (1.5 mg and 6.0 mg, twice daily) of nebulized ensifentrine on top of an inhaled long-acting muscarinic antagonist/long-acting beta2 agonist (LAMA/LABA), tiotropium/olodaterol (Boehringer Ingelheim’s Stiolto Respimat) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Those receiving a stable dose of inhaled corticosteroid (ICS) therapy were allowed to continue throughout the study.
The study failed to achieve the primary endpoint of forced expiratory volume in one second (FEV1), a measure of lung function, after morning dose on day 3 compared to placebo. Peak FEV1 after evening dose on day 3, however, did show statistically significant separation from control for both doses.
Average FEV1 improved over 12 hours following the morning dose of 1.5 mg on days 1-3 but the effect was not statistically significant.
The 6.0 mg dose did not produce a greater improvement in lung function versus the 1.5 mg dose.
A Phase 2 clinical trial assessing a dry powder inhaler formulation of ensifentrine for the maintenance treatment of COPD is in process. It plans to evaluate a metered-dose inhaler formulation as well.
Ensifentrine is an inhaled inhibitor of two enzymes called phosphodiesterase 3 & 4 that have bronchodilator and anti-inflammatory effects. It is being developed to treat COPD, cystic fibrosis and asthma.
Management will host a conference call this morning at 8:00 am ET to discuss the results.
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