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Verona Pharma pushing ahead with development of lead drug despite recent splutter

Verona’s COPD treatment, ensifentrine, failed to meet the primary endpoint in a Phase 2 trial last month, but the results were encouraging enough for the company to keep the faith
man coughing
COPD covers a number of conditions that cause difficulty breathing

Verona Pharma PLC (LON:VRP) is to press ahead with further studies of its lead chronic obstructive pulmonary (COPD) treatment despite last month’s trial failure.

Shares plunged in January when ensifentrine failed to meet the primary endpoint of a mid-stage clinical study.

The three-day Phase II study saw COPD patients given either 1.5mg or 6.0mg of ensifentrine in combination with Stiolto Respimat – a commonly used maintenance treatment for COPD patients.

READ: Verona’s lead COPD drug disappoints

But data showed that the drug did not improve breathing by a “statistically significant” amount on the morning of the third day – the trial’s main goal.

The results were slightly more nuanced than that, though, as patients did register “statistically significant improvements” in breathing on the evening of the third day.

A longer Phase 2b dose-ranging study is now slated to begin in the second quarter with data due by the end of the year.

Verona bosses will then discuss the outcome with US regulators ahead of what they hope will be a Phase 3 trial in 2020.

The company is also working on inhaled versions of ensifentrine. Efficacy and safety data from the first part of a Phase 2 clinical trial is expected within the next few weeks, with data from part two of the study to follow later in the year.

Focus on COPD may limit other indications

A second Phase 2 study, testing a slightly different type of inhaler, is planned to start shortly, with the results due in 2020.

Verona reckons ensifentrine has the potential to be used in other indications such as cystic fibrosis and asthma, but it admits that its decision to proceed more rapidly towards late-stage trials in COPD “may alter our timing to commence further trials using ensifentrine in other indications”.

The AIM company recorded a loss of £19.9mln in the year ended 31 December (2017: £20.5mln). It finished the year with cash of £64.7mln (2017: £80.3mln).

Shares edged 1.9% higher to 54.5p on Tuesday.

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Verona Pharma Timeline

June 20 2016
November 26 2010

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