Sept. 23, 2020: “Verona Pharma, a clinical-stage biopharmaceutical company focused on respiratory diseases, announces the initiation of its ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) Phase 3 trials to evaluate the efficacy and safety of nebulized ensifentrine in patients with moderate to severe chronic obstructive pulmonary disease (“COPD”).
David Zaccardelli, Pharm. D., President and CEO of Verona Pharma, said: “We are excited to start our pivotal ENHANCE Phase 3 studies.
If successful, the data will support the submission of a New Drug Application in the U.S. for nebulized ensifentrine for the maintenance treatment of COPD.
This is an important milestone for Verona Pharma and we look forward to addressing the urgent need for a novel therapy for the treatment of COPD.”
Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound.
In prior clinical studies in COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator.
Ensifentrine has been well tolerated in clinical trials involving more than 1,300 subjects to date.
The two randomized, double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) will evaluate the efficacy and safety of nebulized ensifentrine as monotherapy and added onto a single bronchodilator, either a LAMA (“long acting muscarinic antagonist”) or a LABA (“long acting beta-agonist”), compared to placebo.
The two study designs will replicate measurements of efficacy and safety data over 24 weeks and ENHANCE-1 will also evaluate longer-term safety over 48 weeks.
- Patient Population: Each study will enroll approximately 800 moderate to severe, symptomatic, COPD patients at sites primarily in the U.S. and Europe.
- Dose/Duration: Patients will be randomized to receive a 3 mg nebulized dose of ensifentrine or nebulized placebo twice daily for 24 weeks in ENHANCE-2 or 48 weeks in ENHANCE-1.
- Primary Endpoint: Improvement in lung function as measured by forced expiratory volume* in one second (“FEV1”) over 12 hours with ensifentrine after 12 weeks of treatment.
- Key Secondary Endpoints: COPD symptoms and health-related quality of life through 24 weeks via the validated patient reported outcome tools, SGRQ and E-RS: COPD.
Additional lung function endpoints including peak and morning trough FEV1 will also be assessed.”