Metabolic dysfunction-associated steatohepatitis (MASH) is the most common chronic liver disease globally, affecting approximately 35 million people, with patient numbers rapidly increasing. All major pharmaceutical companies worldwide are actively engaged in the development of new drugs for this condition. Despite one approved drug and several others entering Phase III clinical trials, there remains a substantial market opportunity for MASH, which can accommodate multiple new therapies. According to a 2023 market report by Future Market Insights, the global MASH market is expected to have a compound annual growth rate (CAGR) of 33.3% from 2025 to 2033, reaching $51.4 billion by 2033.
Sinew Pharma’s new drug for steatohepatitis, SNP-630, has shown significant efficacy in clinical trials through its active metabolites. By week 12 of treatment, patients experienced a marked reduction in ALT (alanine aminotransferase) levels compared to pre-treatment baselines, with no severe adverse events observed. Additionally, SNP-630's active metabolites demonstrated anti-fibrotic potential, significantly lowering fibrosis-related biomarkers such as CCL4 and CCL5. FibroScan results also confirmed its effectiveness in improving liver fibrosis.
In terms of its mechanism of action, SNP-630 has shown multiple therapeutic effects in mouse models of steatohepatitis, including significant reductions in liver inflammation, fat accumulation, and fibrosis. Specific data revealed decreases in ALT levels, liver fibrosis area, and fibrosis-related biomarkers such as Col1a1, Col3a1, and Timp-1. Furthermore, in the treated mouse models, triglyceride levels in the liver were significantly reduced after administration of SNP-630 or its active metabolites.
SNP-630’s active metabolites have successfully completed Phase II clinical trials involving 36 participants in both high- and low-dose groups. Interim analysis demonstrated highly significant therapeutic effects compared to pre-treatment baselines, successfully achieving the treatment goals for steatohepatitis. Moreover, SNP-630 has proven to be highly safe in humans and is currently progressing through further Phase II trials. In addition to being a novel compound for treating steatohepatitis, SNP-630 itself exhibits strong pharmacological activity. More than four active metabolites of SNP-630 have been confirmed in vivo to treat steatohepatitis with high safety, directly targeting the liver to reduce fat accumulation and fibrosis biomarkers, ultimately achieving therapeutic outcomes for steatohepatitis.
Resource (mandarin): 欣耀SNP-630機轉及二期人體臨床試驗具顯著抗發炎及抗纖維化療效結果
