(Sharecast News) - Biopharmaceutical company Verona Pharma updated the market on its operations and finances for the three and nine months ended 30 September on Tuesday, highlighting positive results from the second part of its phase 2 study of the dry powder inhaler formulation of 'ensifentrine' in chronic obstructive pulmonary disorder (COPD), delivered by handheld inhaler over one week of twice-daily treatment.
The AIM-traded firm said the trial met all of its primary and secondary lung function endpoints, and said the magnitude of improvement in lung function and duration of action were "highly statistically significant", supporting twice-daily dosing of ensifentrine delivered in a dry powder inhaler format for the treatment of COPD.
It explained that ensifentrine in a handheld dry powder format was well tolerated at all doses, with an adverse event profile similar to placebo, while the safety profile was comparable to that observed in prior studies with nebulised ensifentrine.
The company had also presented at the European Respiratory Society International Congress in Madrid on the positive data from the phase 2 study of the DPI formulation of ensifentrine in COPD.
It said the single dose data was first announced in March, and was followed by positive multiple dose data in August where all the primary and secondary lung function endpoints were met in the phase 2 trial.
The magnitude of improvement in lung function and duration of action were also said to be "highly statistically significant", supporting twice daily dosing of ensifentrine for the treatment of COPD.
Post-period end, on the operational front the company said it had completed enrollment in its phase 2b four-week dose-ranging study evaluating the effect of nebulised ensifentrine as an add-on to inhaled tiotropium - a long acting bronchodilator - in patients with moderate-to-severe COPD.
The enrollment of 416 patients at 46 sites was completed on schedule, with data expected around year-end 2019, and preparations were said to be underway for the end of phase 2 meeting with the US Food and Drug Administration (FDA), which was expected in the first half of 2020.
Additionally, the start of phase 3 trials was expected in 2020.
Looking at the finances, Verona Pharma said its net cash, cash equivalents and short term investments as at 30 September totalled £41.1m, down from £64.7m on 31 December.
For the nine months ended 30 September, the company's reported operating loss widened to £33.7m from £18.3m year-on-year, and its reported loss after tax was £24.5m, compared to £17m.
Operating expenses increased to £33.7m from £18.2m year-on-year, which the board said was due primarily to development activities for ensifentrine.
The company's reported loss per share was 23.3p for the nine months ended 30 September, compared to 16.1p a year earlier.
Net cash used in operating activities for the nine month period totalled £24.5m, rising from £13.1m year-on-year, with the board explaining that the increase in cash used was due to pre-clinical and clinical studies with ensifentrine, and the timing of supplier payments.
"We are very pleased that our four-week Phase 2b dose-ranging clinical trial with nebulised ensifentrine is progressing according to plan and that we have completed enrollment of over 400 symptomatic patients with moderate to severe COPD," said Verona Pharma chief executive officer Jan-Anders Karlsson.
"We anticipate completing this study around the end of 2019. Informed by this and prior studies in around 850 subjects, we plan to advance into our phase 3 clinical trial program which we expect to commence in 2020 following an end of phase 2 meeting with the FDA.
"Millions of COPD patients in the US remain symptomatic and breathless despite being treated with currently available medicines."
Karlsson said the company believed ensifentrine, with its unique dual mode of action and bronchodilator and anti-inflammatory properties, had the potential to become an "important additional treatment option" for many of those patients.
"In particular, the strong reduction in COPD symptoms will be an attractive feature for many of these patients.
"Initially we will focus on nebulised treatment for more severe patients but we are very excited by the positive DPI formulation results that support our view that ensifentrine is an effective bronchodilator in COPD patients, whether administered as a dry powder via a handheld inhaler or as a suspension via a nebuliser."
As at 1104 GMT, shares in Verona Pharma were down 3.08% at 44.1p.
5 Nov 2015 10:50