Ensifentrine

Ensifentrine has the potential to substantially improve both lung function and quality of life of respiratory patients who are not satisfactorily treated with available drugs. We are evaluating nebulized ensifentrine in a Phase 3 clinical program ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) for COPD maintenance treatment. Additionally, two other formulations of ensifentrine are in Phase 2 development for the treatment of COPD: dry powder inhaler (DPI) and pressurized metered-dose inhaler (pMDI).

In Phase 2 studies in patients with moderate-to-severe COPD, our lead formulation, nebulized ensifentrine, has demonstrated significant and clinically meaningful improvements in both lung function and COPD symptoms, including breathlessness. These benefits have been observed with or without background therapy. In addition, nebulized ensifentrine has further improved lung function and reduced residual lung volumes (air trapping) in COPD patients taking standard of care, short- and long-acting bronchodilator therapy, including maximum bronchodilator treatment with dual/triple therapy (LABA/LAMA +/- ICS).

We reported positive results from a Phase 2 study of the DPI formulation of ensifentrine in August 2019. Positive data with a single dose of pMDI formulation of ensifentrine in a Phase 2 trial were reported in March 2020 and with multiple doses in February 2021. Ensifentrine also has potential applications in cystic fibrosis, asthma and other respiratory diseases.