Verona Pharma is progressing a Phase II trial of new inhaler formulation of ensifentrine following a coronavirus pandemic-induced pause.
The company said it has now kicked off the second, multiple dose, part of a Phase II trial to evaluate the pressurised metered-dose inhaler (pMDI) formulation of ensifentrine in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
The move follows positive efficacy and safety data from the first, single dose, part of the study (Part A) in 40 patients with moderate to severe COPD, announced by the company earlier this year, which showed a “statistically significant and clinically meaningful increase in lung function”, as measured by forced expiratory volume in one second (FEV1) versus placebo.
Verona had postponed initiation of Part B of the study due to concerns for the safety of patients and study staff because of the COVID-19 pandemic, but following an assessment of local infection rates and control measures is now continuing as planned.
“We are pleased to start the multiple dose part of this pMDI study and expect the results in the first half of 2021,” said David Zaccardelli, the company’s president and chief executive.
“Data from the single dose part of this pMDI study are very encouraging and consistent with data from Phase II clinical trials with our nebulised and dry powder inhaler formulations of ensifentrine.”