Enrollment Complete – Tops 800 – in ENHANCE-1 Trial of Ensifentrine
Enrollment is now complete in ENHANCE-1, a Phase 3 clinical trial testing Verona Pharma’s experimental inhalation therapy ensifentrine in more than 800 people with chronic obstructive pulmonary disease (COPD).
The announcement comes less than five months after Verona completed enrollment in its other Phase 3 trial testing ensifentrine, ENHANCE-2 (NCT04542057). Results from both trials are expected before the end of the year.
“We are pleased to complete enrollment in the Phase 3 ENHANCE program with more than 1,600 subjects randomized across the two trials,” David Zaccardelli, president and CEO of Verona, said in a press release.
“Attaining our recruitment targets across multiple international sites during the ongoing pandemic is a significant achievement and we would like to thank the patients and healthcare professionals who helped us reach this important milestone,” Zaccardelli added.
Ensifentrine is a first-in-class therapy that is designed to simultaneously exert anti-inflammatory effects and act as a bronchodilator — a substance that prompts airways to widen. It works by blocking the activity of two enzymes, phosphodiesterase 3 and 4 (PDE3 and PDE4).
The ENHANCE program is testing ensifentrine — given as a 3 mg nebulized dose twice daily — against a placebo in people with moderate to severe COPD. Both trials are double-blind, meaning that neither the participants nor the researchers know which patients are receiving the medication and which the placebo.
Participants in ENHANCE-1 (NCT04535986) will be randomly assigned to take either ensifentrine or the placebo, either alone or in addition to a standard bronchodilator. Those using a bronchodilator will receive either a long-acting muscarinic antagonist (LAMA) or a long-acting beta-agonist (LABA). Treatment will last for either six months (24 weeks) or a year (48 weeks).
The study’s main goal is to assess the impact of treatment on lung function after 12 weeks, or about three months. Specifically, participants will be evaluated on forced expiratory volume in one second, a parameter that measures how much air a person can forcefully exhale in one second. Other measures of lung function, in addition to assessments of COPD symptoms, health-related quality of life, and safety, also will be evaluated.
If results from the ENHANCE clinical trials are positive, these studies are expected to support applications requesting the approval of ensifentrine for the treatment of COPD.
Data from a previous Phase 2b trial (NCT03937479), which tested ensifentrine in combination with a bronchodilator in people with COPD, suggested that the therapy significantly improved lung function and quality of life.