Verona Pharma has reported positive efficacy and safety data from ensifentrine in chronic obstructive pulmonary disease (COPD) patients, in which the drug demonstrated a meaningful increase in lung function as measured by forced expiratory volume (FEV) in one second compared to placebo.
The company revealed that the single dose of pressurised metered-dose inhaler formulation showed improvements in peak FEV, average FEV over four hours and average FEV over 12 hours.
The ensifentrine pMDI formulation was also well tolerated at each dose with an adverse event profile similar to placebo.
Verona has announced that off the back of the positive data, it will initiate a second, multiple dose, part of the study (Part B), which will evaluate the pMDI formulation in this patient population over seven days of twice daily treatment.
However, the company has decided to postpone the initiation of Part B due to concerns regarding the safety of trial subjects, caregivers and medical staff during the COVID-19 pandemic.
David Zaccardelli, president and chief executive officer of Verona Pharma, commented: “Across all three inhaled formulations, ensifentrine has demonstrated statistically significant and clinically meaningful lung function improvements and duration of action, supporting twice-daily dosing and a safety profile similar to placebo.
“The results from the single dose part of this pMDI study are very encouraging and essentially consistent with data from Phase II clinical trials with nebulized and DPI formulations of ensifentrine.”
He went on to explain that “Following the public health advice associated with COVID-19, we have postponed enrolment of Part B of our pMDI Phase III trial in COPD. Our planned End-of-Phase II meeting with the FDA is scheduled in the second quarter of 2020, and the initiation of our Phase III trials of nebulized ensifentrine is planned for later this year.”
COPD happens when the lungs become inflamed, damaged and narrowed. The main cause is smoking, although the condition can sometimes affect people who have never smoked.
The likelihood of developing COPD increases the more you smoke and the longer you’ve smoked.
Some cases of COPD are caused by long-term exposure to harmful fumes or dust. Others are the result of a rare genetic problem which means the lungs are more vulnerable to damage.
