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Verona Pharma Reports Encouraging Top-Line Data from Three-Day Phase 2 Trial Evaluating Nebulized Ensifentrine (RPL554) on Top of Dual Bronchodilator Therapy for COPD Maintenance Treatment

GlobeNewswire Monday, 14 January 2019
Results from this short clinical pharmacology trial inform and support further clinical development of ensifentrine as an add-on to dual and triple COPD therapyInvestment community conference call scheduled for 8 am EST on Monday, January 14, 2019

LONDON, Jan. 14, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM:VRP) (Nasdaq:VRNA) (“Verona Pharma”), 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^®). LAMA/LABA therapies are commonly used in the maintenance treatment of patients with moderate to severe chronic obstructive pulmonary disease (“COPD”). Patients already receiving inhaled corticosteroid (“ICS”) therapy were allowed to continue to receive a stable dose of ICS throughout the study, thus providing additional data on “triple therapy” use.

Ensifentrine is an investigational first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have bronchodilator and anti-inflammatory properties, which is currently in development for the maintenance treatment of COPD, cystic fibrosis and asthma.

*Highlights*

· Primary endpoint of peak forced expiratory volume in one second (“FEV[1]”) after morning dose on day 3 of treatment was not met with statistical significance, although the ensifentrine 1.5 mg morning dose improved peak FEV[1] by 46 mL, compared to placebo.
- Improvement in FEV[1], compared to placebo, with the 1.5 mg dose was maintained throughout the 24-hour period as measured on day 3.
· Importantly, peak FEV[1] after evening dose on day 3 showed statistically significant improvement, compared to placebo, with both doses, with ensifentrine 1.5 mg showing a 130 mL improvement (p
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