Verona Pharma (NASDAQ:VRNA) jumps 10% premarket after initiating the second, multiple dose, part of a Phase 2 trial to evaluate the pressurized metered-dose inhaler (“pMDI”) formulation of ensifentrine in patients with moderate to severe chronic obstructive pulmonary disease (COPD), a type of progressive lung disease characterized by long-term breathing problems and poor airflow.
Results from the study (Part B) are expected in H1 2021.
Positive efficacy and safety data from Part A of the study in 40 patients were announced on March 31, 2020.
Details of Part B Crossover trial are as follows:
Patient Population: Approx. 30 patients who participated in Part A are planned to continue to Part B at two sites in UK.
Dose/Duration: Patients will be randomized to receive 3 dose levels (300 µg, 1000 µg, 3000 µg) of pMDI ensifentrine or placebo, twice-daily over one week.
Primary Endpoint: Improvement in lung function as measured by peak FEV1 with ensifentrine compared to placebo after 7 days of treatment.
“Data from the single dose part of this pMDI study are very encouraging and consistent with data from Phase 2 clinical trials with our nebulized and dry powder inhaler formulations of ensifentrine,” said David Zaccardelli, Pharm. D., President and CEO.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.