14th Jan 2019 09:47
LONDON (Alliance News) - Verona Pharma PLC on Monday said its phase two clinical trial of nebulized Ensifentrine did not meet its primary endpoint but did perform better than placebo.
Shares in the biopharmaceutical firm were down 17% at 86.00 pence on Monday.
The three-day phase two clinical pharmacology trial of Ensifentrine in moderate to severe chronic obstructive pulmonary disease patients did not meet its primary endpoint.
COPD is a the name for a number of conditions that cause difficulty breathing.
In this trial, nebulized Ensifentrine was given in combination with Stiolto Respimat, a commonly used maintenance treatment for COPD patients.
The trial evaluated the effect of two different doses, 1.5 milligrams and 6.0 milligrams, twice a day.
The primary endpoint of the study was to achieve peak forced expiratory volume in one second, or FEV1, after the morning dose on day three of the trial, and this was not met with statistical significance.
Forced expiratory volume is the maximum amount of air that can be exhaled after taking the deepest breath possible.
However, although Ensifentrine did not meet its primary endpoint, the 1.5 milligram morning dose did improve peak FEV1 by 46 millilitres versus placebo.
Moreover, an improvement in FEV1 compared to placebo with the 1.5 milligram dose was maintained throughout the 24 hour period on day three.
In addition, after the evening 1.5 milligram and 6.0 milligram doses on day three, peak FEV1 showed statistically significant improvement over placebo. The 1.5 milligram Ensifentrine dose showed a 130 millilitre improvement.
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