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Verona's shares drop 34% on Phase 2 failure of nebulised ensifentrine in COPD

Published on 15/01/19 at 11:08am

Verona Pharma has seen its shares crater following the Phase 2 failure of its nebulised ensifentrine, known as RPL554, in combination with Boehringer’s Stiolto Respimat (tiotropium/olodaterol) in the treatment of chronic obstructive pulmonary disease (COPD).

Share value fell by as much as 34% when news broke that the therapy failed to meet statistical significance in its primary endpoint of improving lung function compared to placebo, as measured by peak forced expiratory volume in one second (FEV1).

In the trial, 79 participants received either 1.5mg or 6.0mg of nebulised ensifentrine or placebo, administered twice daily, in addition to Stiolto Respimat. Around 40% of this number were also already receiving inhaled corticosteroid therapy.

Although the primary endpoint was not met, Verona did note that the 1.5mg dose did improve peak FEV1 by 46mL compared to placebo, and this improvement was maintained for the 24 hours following the first measurement on the third day of treatment. After the second dose on the third day, peak FEV1 with the lower dosage was improved by 130mL compared to placebo and 81 mL for the higher dosage.

Despite the ostensible failure of the trial, Verona CEO Dr Jan-Anders Karlsson remained positive, commenting: “Having demonstrated in previous studies the potential of ensifentrine to deliver benefits to patients on no or single bronchodilator therapy, we believe that this short study continues to support our view that ensifentrine may also be of benefit to more severe COPD patients on dual and triple therapy, for whom there are few other treatment options.

“While we are disappointed that this exploratory Phase 2 study did not achieve statistical significance for its primary endpoint, these data give us clarity on the design, including dose and background therapy, for future long-term studies,” he continued. “We now have the opportunity to also include patients on dual and triple therapy, with the goal of further evaluating ensifentrine’s potential to produce sustained bronchodilation and anti-inflammatory effect in this large number of symptomatic COPD patients.”

Matt Fellows

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