According to a press release from American biotechnology company Intercept Pharmaceuticals, the company recently released additional data supporting its phase 3 clinical trial of obeticholic acid (OCA) in the treatment of nonalcoholic steatohepatitis (NASH)-linked fibrosis of the liver.
The new data also suggested that OCA improved other factors linked to overall liver health.
About Nonalcoholic Steatohepatitis
Nonalcoholic steatohepatitis is a kind of nonalcoholic fatty liver disease (NFLD). NFLDs are conditions where excessive fat accumulation causes inflammation and damage to the liver in individuals who consume little alcohol.
Many people have some fat buildup in their liver with little impact. However, in individuals with NASH, this buildup can be significant and cause inflammation of the liver that leads to scarring – leading to a serious condition called cirrhosis where the liver can become permanently damaged.
About the Phase 3 Study
The phase 3 study of obeticholic acid involved thousands of patients with fibrosis linked to NASH. For the primary efficacy analysis, 931 participants were divided into three equally-sized groups, receiving either a placebo, a 10mg, or a 25mg dose of OCA once daily for over a year. Biopsies conducted at the beginning and end of the study evaluated the progression of the patients’ fibrosis.
The OCA was found to improve the fibrosis of some patients – 23.1% of patients taking the 25mg dose of OCA daily experienced an improvement in the stage of their fibrosis (graded by stage according to severity). Just 11.9% of the placebo group experienced a similar reduction in the severity of their fibrosis.
Secondary findings, published after further study of the collected data, showed that respondents in the 25mg OCA group were three times more likely to have their fibrosis improve by two or more stages than their peers in the control group. Members of the 25mg OCA group were also three more times likely to improve a fibrotic stage than worsen by one – members of the control group were about 50-50 as to whether their fibrosis improved or worsened.
The findings are encouraging, of course. The most frequently-reported adverse effect following OCA administration was merely the development of an itchy rash. The possibility of a new NASH-linked fibrosis treatment could mean serious quality of life improvement for the roughly 6% of American adults who might have some form of nonalcoholic steatohepatitis.
NASH makes up about 1/5 of cases of NFLD – one of the most common causes of liver disease in the United States. Do you think an effective treatment for NASH-linked fibrosis could open the door for liver treatments for other Americans? Share your thoughts with Patient Worthy!