Benzinga | Oct 13, 2021 01:38PM EDT

Verona Pharma Earlier Announced Co. Will Present Phase 2 Data With pMDI Ensifentrine In COPD At CHEST 2021

Verona Pharma plc (NASDAQ:VRNA) ("Verona Pharma"), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces the presentation of Phase 2 data demonstrating the positive effect of a pressurized metered-dose inhaler ("pMDI") formulation of ensifentrine in patients with moderate to severe chronic obstructive pulmonary disease ("COPD") at CHEST Annual Meeting ("CHEST") 2021 taking place on October 17-20. The data are published in the CHEST Annual Meeting on-line supplement.

Data from Part B of the two-part study, first reported on February 2, 2021, showed ensifentrine delivered by pMDI over one week provided statistically significant, clinically meaningful and dose-dependent improvements in lung function and was well tolerated with an adverse advent profile similar to placebo. The data are consistent with results for dry powder inhaler ("DPI") and nebulizer formulations of ensifentrine.

Ensifentrine is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3" and "PDE4"). Verona Pharma is currently conducting a global Phase 3 program evaluating ensifentrine for the treatment of COPD with top-line results expected in 2022.

The randomized, double-blind, placebo-controlled two-part Phase 2 study evaluated pMDI ensifentrine for the treatment of moderate to severe COPD after a single dose and repeat doses over 7 days. Part A of the study evaluated the pharmacokinetic profile, safety and efficacy following a single dose of ensifentrine over 5 dose levels in a parallel group design. Part B of the study was designed to evaluate the efficacy, safety and pharmacokinetic profile of ensifentrine given twice daily over 7 days compared with placebo. Patients (N=28) who completed Part A were randomized to receive 3 doses of ensifentrine (300, 1000 or 3000 mcg) or placebo in a complete block crossover design. The primary endpoint in Part B was the change from baseline in peak forced expiratory volume in one second ("FEV1") over 4 hours post-dose after 7 days of treatment compared with placebo.