(Alliance News) - Verona Pharma PLC on Monday said its Phase 2b clinical trial of nebulized Ensifentrine met its primary endpoint.
The four-week Phase 2b trial of the drug in moderate to severe chronic obstructive pulmonary disease patients improved lung function at week four of the treatment.
In the trial, the drug was administered twice daily in combination with tiotropium, a treatment used in the management of chronic obstructive pulmonary disease and asthma.
The trial evaluated the effect of four different doses - 0.375 milligram, 0.75 milligram, 1.5 milligrams and 3.0 milligrams - with significant improvement in average FEV1 for the 0.375 milligram dose at 78 millilitre, and for the 3.0 milligram dose at 124 millilitres.
FEV or forced expiratory volume is the maximum amount of air that can be exhaled in one second after taking the deepest breath possible.
Verona said the drug hit its "primary endpoint" for a dose-related positive effect on lung function when compared with a group taking a placebo that has no medical benefit.
"We are delighted with these results in symptomatic COPD patients already on steady-state maintenance treatment. These data bring clarity to planning the design, including dose selection, endpoints and background therapy, of our Phase 3 program. We expect Phase 3 trials to start in the third quarter of 2020," said Verona Pharma CEO Jan-Anders Karlsson.
"We look forward to discussing these new and compelling data, together with the positive results from our previous clinical studies, in an End-of-Phase 2 meeting with the FDA planned for the second quarter," he added
By Ife Taiwo; ifetaiwo@alliancenews.com
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