Verona Pharma PLC (LON:VRP), the respiratory drugs specialist, expects 2020 to be a transformational year for the company.
The company recently brought in David Zaccardelli as chief executive and Mark Hahn as the chief financial officer and the pair are keen to use their industry experience to lead Verona through late-stage clinical trials and into the commercialisation phase.
“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,” Zaccardelli said in the company's results statement for 2019.
Since the end of the reporting period, the company has reported positive top-line data from a Phase 2b clinical study in symptomatic patients with moderate to severe chronic obstructive pulmonary disease (COPD). The study 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.
“In the US alone, over 1.2 million COPD patients remain symptomatic despite treatment with current maximal therapy. We believe ensifentrine will be an important therapy for these patients. Beyond the first indication for nebulised ensifentrine, we continue progressing both dry powder inhaler ... and pressurised metered dose inhaler … formulations for COPD patients and ultimately advancing into asthma and cystic fibrosis indications,” he added.
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.