Verona Pharma Provides Clinical Development Update

Verona Pharma plc recently announced updated projections, bringing forward the timing for top-line data readouts from its ongoing clinical trials in chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF).

-Phase 2b clinical trial of nebulized RPL554 for COPD Maintenance Treatment: The company anticipates reporting top-line data from its Phase 2b trial early in the second quarter of 2018 (previously mid-2018). The four-week, double-blind, placebo-controlled, parallel group Phase 2b study enrolled approximately 400 patients with moderate-to-severe COPD at a number of sites across Europe and is investigating the efficacy, safety, and dose-response of nebulized RPL554 as a maintenance treatment for COPD.

-Phase 2a pharmacokinetic (PK) and pharmacodynamic (PD) clinical trial of RPL554 for CF: The company anticipates reporting top-line data from its Phase 2a trial in late first quarter of 2018 (previously first half of 2018). The double-blind, placebo-controlled, cross-over Phase 2a study is evaluating the PK and PD profile and tolerability of single nebulized dose of RPL554 in 10 patients with CF, as well as the effect on lung function in such patients.

“We are pleased to be making excellent progress in these important studies,” said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. “We have completed the clinical phase of both studies ahead of schedule and now look forward to reporting top-line data sooner than our previous guidance.”

RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have anti-inflammatory as well as bronchodilator properties, and is currently in development for the maintenance treatment of COPD patients and for the treatment of patients with CF. In pre-clinical studies, RPL554 has been observed to stimulate the CF transmembrane conductance regulator, a protein whose mutation results in dysfunctional ion channels in epithelial cells, leading to CF. Based on available data, RPL554 has the potential to enhance mucociliary clearance (reduce phlegm in the airways), reduce airway obstruction and inhibit inflammation.

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. Verona Pharma’s product candidate, RPL554, is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that acts as both a bronchodilator and an anti-inflammatory agent in a single compound. In clinical trials, treatment with RPL554 has been observed to result in statistically significant improvements in lung function as compared to placebo, and has shown clinically meaningful and statistically significant improvements in lung function when administered in addition to frequently used short- and long-acting bronchodilators as compared to such bronchodilators administered as a single agent. Verona Pharma is developing RPL554 for the treatment of chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), and potentially asthma.