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Verona Pharma looks forward to phase III ensifentrine trials


A phase IIb study is currently underway for the nebulised version of ensifentrine with the read-out expected “around the end of the year”

Verona Pharma -

Quick facts: Verona Pharma

Price: 56.95 GBX

Market: AIM
Market Cap: £59.98 m

What it does

Verona Pharma PLC (LON:VRP)  is a clinical stage biopharmaceutical company focused on the development and commercialization of innovative prescription medicines to treat respiratory diseases with significant unmet medical needs, such as chronic obstructive pulmonary disease (COPD), cystic fibrosis and asthma.

COPD is a progressive and life-threatening disease which the World Health Organisation predicts will be the third leading cause of death by 2030. In the US alone, the cost of treating COPD is expected to hit US$49bn next year.

Verona is developing a first-in-class drug known as ensifentrine, which opens patients’ airways and reduces inflammation in the lungs by inhibiting the enzymes phosphodiesterase 3 and 4.

Importantly, ensifentrine has not shown the nasty side effects such as nausea, vomiting and weight loss, that halted previous attempts to develop similar drugs.

Two versions of the drug are under development. The first is a nebulised version for moderate-to-severe COPD patients, which has been designed both for hospital and at-home use.

When using a nebuliser, patients can breathe at their own pace as they inhale the drug, and feel confident that they are getting the dose as they can see it disappear.

The second version is a dry powder formulation to be used in a handheld inhaler, which is “a little more tricky” to use, but results from a phase IIb study already showed it meeting all of its primary and secondary lung function targets, or endpoints.

As of November, Verona was worth £45.3mln, with shares trading at around 44p each.

Inflexion points

A phase IIb study is currently underway for the nebulised version of ensifentrine, with the read-out expected “around the end of the year”.

Preparations are already underway for what’s called an end of phase II meeting with the US regulator that would clear the path for a final-stage assessment of the medication in 2020.

After that, phase III studies will begin, after which Verona is expecting the nebulised ensifentrine to hit shelves in 2022/2023.

As for the dry powder, the company says it will be looking for partners next year, especially to help with commercialising it.

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What the boss says

“Millions of COPD patients urgently need better treatments as they remain symptomatic despite maximum treatment with currently available therapies,” Verona chief executive Jan-Anders Karlsson said.

“We believe ensifentrine, with its unique dual mode of action and bronchodilator and anti-inflammatory properties, has the potential to become an important additional treatment option for many of these patients.”

“Over the next one or two years there will be many important milestones,” he added, noting big value increases to come once phase II is complete, and another big value increase on an agreement with the FDA.

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