Gilead Expands its Collaboration with Novo Nordisk to Evaluate Triple Combination Regimen for Compensated Cirrhosis (F4) due to NASH

Shots:

• The companies plan to initiate a P-IIb study assessing NovoNordisk’s semaglutide and FD combination of Gilead’s cilofexor + firsocostat vs PBO in ~440 patients with compensated cirrhosis (F4) due to NASH
• The trial will evaluate the therapeutic effect on liver fibrosis improvement and NASH resolution and expected to initiate recruitment in H2’21 The new P-IIb study results built on the P-IIa POC study which met its 1EPs demonstrated that all regimens were well tolerated @24wks.
• Additionally, post-hoc analyses evaluating biomarkers of liver health @24wks. showed significant improvements in hepatic steatosis and liver injury. Liver stiffness and ELF score declined in all groups

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