Gelonghui, April 3 | Junshengtai Pharmaceutical-B (02511.HK) announced that the Phase IIb clinical trial of the enterohepatic anti-inflammatory and metabolic regulator HTD1801 (Xiongdeoxycholic Berberberis) independently developed by the company has been enrolled. The trial targets patients with metabolic fatty hepatosis (MASH for short) with type 2 diabetes (T2DM) or pre-diabetes.
This trial (Centricity Study) is a randomized, double-blind, placebo-controlled global multi-center phase IIb clinical trial to evaluate the safety and efficacy of HTD1801 in patients with metabolic steatohepatitis. Patient enrollment began in December 2022. As of the date of this announcement, a total of 218 patients from the United States, Hong Kong and mainland China were enrolled. The primary endpoint of this Centricity study was improvement in liver histology. In November 2018, the US Food and Drug Administration granted HTD1801 fast-track qualification for the treatment of patients with metabolic fatty hepatosis (non-alcoholic steatohepatitis).
Metabolic steatohepatitis is a serious chronic liver disease. It is also one of the main causes of morbidity and mortality from liver-related diseases, affecting about 5% of the global population. Due to the growing prevalence of obesity, its global incidence is rising. Without treatment, metabolic steatohepatitis may progress to advanced liver fibrosis, cirrhosis, decompensated liver function, hepatocellular carcinoma, liver transplantation, or death. Metabolic steatohepatitis is a clinical manifestation of liver metabolic syndrome. It is closely related to visceral obesity, and is characterized by cardiovascular risk factors such as insulin resistance, type 2 diabetes, abnormal blood lipids, and high blood pressure.
Patients with metabolic steatohepatitis and various metabolic abnormalities are at greater risk of histological deterioration and all-cause death. Due to the complexity and heterogeneity of the causative factors of this disease, treatment of metabolic steatohepatitis is trending towards multi-functional therapy, particularly treatment for liver fibrosis and cardiovascular risk factors (i.e. type 2 diabetes, obesity, dyslipidemia).