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Verona Pharma looks forward to phase III ensifentrine trials

Snapshot

  • AIM-listed biotech developing respiratory disease treatments
  • Nebulizer version of COPD drug expected to enter phase III trial later this year
  • COPD a major cause of death globally
Verona Pharma -

Quick facts: Verona Pharma

Price: 49.5 GBX

AIM:VRP
Market: AIM
Market Cap: £52.71 m
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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.

Verona is developing three formulations of ensifentrine for COPD: nebulised, dry powder inhaler and pressurised metered-dose inhaler.

To provide a sense of the scale of the opportunity being chased by Verona, an estimated 5.5mln people in the US alone use metered dose and dry powder inhalers to control the symptoms of COPD, a disease characterised by long-term breathing problems and poor airflow. Sales of these maintenance medications stateside were US$9bn last year.

 

How it is doing

In May, the firm received the regulatory green light for two phase III studies of the nebulised formulation of its drug.

The ENHANCE programme will consist of two randomised, double-blind, placebo-controlled studies.

They will evaluate the efficacy and safety of twice-daily nebulised ensifentrine as a stand-alone therapy and as an add-on to the standard of care treatment.

As of the end of March, the company had cash of £20.8mln and in April it received £7.3mln in the form of an R&D tax credit. As you’d expect from a company investing heavily in drug development, Verona was loss-making – to the tune of £9.6mln at the post-tax level for the first three months of 2020.

 

What the boss says: David Zaccardelli, chief executive

"We continue to be very encouraged by the phase II results that have demonstrated ensifentrine’s effects on lung function, COPD symptoms and quality of life as well as its favourable safety profile.” 

“We look forward to building on this positive data to support the potential submission of a new drug application for ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease.”

 

Inflexion points

  • Phase III studies for nebulised ensifentrine
  • Product might hit the shelves in 2022/2023

 

 

 

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