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Verona Pharma looks forward to phase III ensifentrine trials

Snapshot

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: 46 GBX

AIM:VRP
Market: AIM
Market Cap: £48.98 m
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  • 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

How it's doing

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.

The company recently brought in industry veterans David Zaccardelli as chief executive and Mark Hahn as chief financial officer. 

The pre-revenue biopharmaceutical company saw losses widen to £39.2mln in 2019 from £24.1mln the year before as it cranked up its research and development (R&D) efforts; R&D costs rose to £33.5mln from £19.3mln in 2018.

Tax credits reduced the losses to £31.9mln (2018: £19.9mln).

Cash, cash equivalents and short-term investments at the end of 2019 stood at £30.8mln, compared to £64.7mln at the end of 2018.

 

What the boss says: David Zaccardelli, CEO 

“We are looking forward to our planned End-of-Phase 2 meeting with the US FDA [Food and Drug Administration] in the second quarter and initiating our Phase 3 programme for ensifentrine in the treatment of COPD later this year,”

Top-line data from a Phase 2b clinical study in symptomatic patients with moderate to severe chronic obstructive pulmonary disease (COPD met the primary endpoint at all doses and also met clinically relevant secondary endpoints.

“We believe that ensifentrine, with its novel mechanism of action possessing both bronchodilation and anti-inflammatory activity in a single agent, has the potential to significantly benefit COPD patients,” Zaccardelli said.

 

Video

Inflexion points

  • Phase III studies for nebulised ensifentrine
  • Product might hit the shelves in 2022/2023.
  • Company is looking for a partner for its dry powder formulation

Blue Sky 

“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.”

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