Shots:
The P-III (ENHANCE-2) trial evaluates the efficacy & safety of ensifentrine (3mg) as monothx. & added on to LAMA or LABA vs PBO in 800 patients with COPD across US & EU for 24wks. The results are expected in Q3’22 while (ENHANCE-1) trial result at the end of 2022
The 1EPs include an improvement in lung function over 12hrs. after 12wks. The 2EPs include COPD symptoms & health-related QoL @24wks. via validated PROs tools, SGRQ & E-RS while an additional lung function EPs including peak & morning trough FEV1 will also be evaluated
The company is planning to file an NDA with the US FDA in H1’23. In prior clinical studies, the therapy showed improvements in lung function, symptoms & QoL
Ref: Globe Newswire | Image: Share Talk
