Metabolic dysfunction-associated steatohepatitis, MASH (formerly known as non-alcoholic steatohepatitis, NASH)

Based on the current cellular, animal and clinical studies, a multi-target MASH treatment may be achieved through the following mechanisms:

1. Inhibit fat synthesis and accumulation via impeding the synthesis and accumulation of triglycerides, and hindering the absorption of fatty acids by liver cells.
2. Reduce ROS production.
3. Inhibit the expression of pro-fibrotic factors and pro-inflammatory factors by regulating immune cells and hepatic stellate cells.
4. Reduce subsequent inflammatory reactions in the liver by regulating the integrity of the intestinal cell barrier.

Phase IIa clinical study was approved by US FDA & TFDA.

1. An innovative combination of active ingredients for a new indication.
2. First-in-class new drug on the market.
3. Treatment for both alcoholic steatohepatitis and MASH.
4. No safety issue.

The global market size of MASH is expected to reach US$35 billion to US$40 billion in 2025, as forecasted by Deutsche Bank and Evaluate Pharma.

Clinical trials

1. Clinical phase II POC study was completed in 2021, with a total of 36 subjects from both the high and low dose groups. Post-treatment of SNP-610 for 12 weeks, the primary efficacy endpoint ALT (approved to use by the US FDA) and other secondary clinical efficacy endpoints were met, and a significant therapeutic effect was observed for MASH treatment when compared with the baseline.
2. A double-blind controlled clinical phase II (2a) trial has obtained approval to proceed from the US FDA & TFDA. The main objective of the trial is to verify the efficacy and safety, and compare the differences in various efficacy and safety endpoints between the SNP-610 group and the placebo group. The enrollment is expected to be around 80 subjects.