Pipeline

SNP-610
Indication

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

Mechanism of Action

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.
Current Status

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

Product Advantages
  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.
Market Potential

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.

Development Progress (as of 2023/12/07)

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.

SINEW is adopting a comparable strategy as other pharmaceutical companies of concurrently developing several new drugs for MASH. This includes the development of SNP-610, a drug featuring an innovative combination of active ingredients for a new indication, as well as SNP-630, a new chemical entity (NCE). The rationale is to increase the probability of success for MASH drug development, as it is not yet confirmed whether the development of a single-target drug can completely cure MASH, a disease with complex etiology. Up until now, no drug has been approved globally for this condition.

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