dm+d

Unassigned

New Medicines

Non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis

Information

New molecular entity
Allergan
Allergan

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Feb 21Development discontinued [11].

Category

A small molecule dual chemokine receptor 5 (CCR5) and chemokine receptor 2 (CCR2) antagonist.
NAFLD is accumulation of fat in the liver, which is not due to alcohol. When inflammation is present, it becomes non-alcoholic steatohepatitis (NASH), which can progress to cirrhosis and hepatocellular carcinoma. In Europe, prevalence of NAFLD is estimated at 20-30% in the general population and 2.6-10% in the paediatric population. Prevalence of NASH is approximately 5%. Fatty liver develops in up to 94% of obese individuals [2].
Non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis
Oral

Trial or other data

Jan 21PIII AURORA (NCT03028740) trial terminated early due to lack of efficacy based on the results of Part I of the study which was examining the surrogate endpoint of improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research network [NASH CRN]) and no worsening of steatohepatitis at month 12 [12].