Verona Pharma Plans NDA for Experimental COPD Drug Ensifentrine
By Alex Keown
May 11, 2023
Verona Pharma is on track to submit a New Drug Application for its experimental maintenance treatment for chronic obstructive pulmonary disease (COPD) that the company believes has the potential to become a transformative medication for patients across the globe.
David Zaccardelli, president and chief executive officer of Raleigh-based Verona Pharma, said the company is on track to file the NDA in the second quarter of 2023, maintaining a timeline announced earlier this year. During a May 9 investor call discussing the company’s quarterly financial report, Zaccardelli said Verona’s leadership team believes they and the FDA are aligned on the appropriate data expected to be submitted with the NDA for ensifentrine, the company’s experimental COPD treatment.
Ensifentrine is an investigational, first-in-class, selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 that combines bronchodilator and anti-inflammatory activities in one compound.
The NDA will consist of data from Verona’s Phase III ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD therapy) study as well as other appropriate clinical data the company accumulated, Zaccardelli said. Data from the ENHANCE studies (ENHANCE 1 and ENHANCE 2) showed ensifentrine demonstrated both statistically significant and clinically meaningful improvements in both lung function measures and the rate of exacerbations associated with COPD, a group of diseases associated with airflow blockage and breathing-related problems.
It is estimated that approximately 16 million people in the United States suffer from COPD, with millions more being undiagnosed. Globally, there are more than 216 million cases of reported COPD. With more than three million annual related deaths, COPD is the third leading cause of death worldwide. There are multiple COPD treatments currently available, including several developed by U.K.-GSK, which also has a significant presence in Research Triangle Park.
“New and effective COPD therapies are needed. We believe ensifentrine, if approved, has the potential to change the treatment paradigm for COPD. With its novel mechanism of action… we believe it will be a transformational advance for COPD patients,” Zaccardelli said. “The totality of data from clinical trials, in particular our top-line data from the ENHANCE program including improvements in lung function, symptoms and quality of life measures, and remarkable reduction in the rate and risk of COPD exacerbations, combined with ensifentrine’s favorable safety profile, support our belief in the pioneering potential of ensifentrine.”
Zaccardelli added that ensifentrine has the potential to be the “first novel MOA (mechanism of action)” launched for the maintenance of COPD in more than 10 years.
Zaccardelli said the company is eyeing a transformational year. If ensifentrine is approved, Zaccardelli anticipates commercial launch in the second half of 2024. He noted during the call that Verona Pharma has been laying the groundwork for its commercial team since August 2022, following the first readouts from ENHANCE 2.
Additional analyses from both ENHANCE 1 and ENHANCE 2 will be presented later this month at the American Thoracic Society International Conference. Verona Pharma will provide an update on the NDA and the presentation later this quarter, Zaccardelli said.
In addition to its planned NDA with the FDA, Verona and its Chinese development partner Nuance Pharma are moving forward with a Phase III study assessing ensifentrine for the maintenance treatment of COPD in China. Zaccardelli said this is a significant milestone for the company and potential expansion of availability of ensifentrine. Verona and Nuance first forged their partnership in 2021.
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Alex Keown is a freelance journalist who writes about a variety of subjects including the pharma, biotech, and life science industries. Prior to freelancing, Alex has served as a staff writer and editor for several publications.
