Shots:

• The two P-III studies (ENHANCE-1 & ENHANCE-2) will assess the efficacy and safety of nebulized ensifentrine (3mg- bid) as monothx. and added onto a single bronchodilator either a LAMA/ LABA vs PBO in ~800 patients with mod. to sev. COPD at sites primarily in the US and EU for 24wks. & 48wks. respectively
• The 1EPs will be the improvement in lung function as measured by FEV1 over 12hrs. following 12wks. of treatment while 2EPs will be COPD symptoms and health-related QoL through 24wks. Additional lung function endpoints including peak and morning trough FEV1 will also be assessed
• If successful- the data will support the NDA submission to the US FDA. Ensifentrine is a first-in-class therapy that combines bronchodilator and anti-inflammatory activities in one compound

­ Ref: Verona | Image: Share Talk