This product is an innovative drug developed by Sinew Pharma, currently in Phase II clinical development, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Classified as a new chemical entity (NCE), the drug features multiple mechanisms of action and targets. It has successfully completed a low-dose Phase II clinical trial and is now advancing into high-dose clinical evaluation.

MASH progression is characterized by persistent liver inflammation and cellular injury, leading to fibrosis — the formation of scar tissue within the liver. Over time, fibrosis worsens as hardened scar tissue gradually replaces healthy liver tissue, eventually resulting in cirrhosis. With its multi-target, multi-mechanism design, this novel drug offers a comprehensive approach to modulating liver inflammation and inhibiting fibrosis, providing new hope for patients with MASH.

More details: https://sinewpharma.com/en/products-detail2-3.htm

1. Optimized New Chemical Entity (NCE)
A newly designed and optimized small-molecule compound. In a Phase II clinical trial (TSGH IRB No. 1-106-05-062) involving 36 subjects, both low- and high-dose groups demonstrated significant ALT reduction at 12 weeks (SNP-610: -29.5 U/L) compared with baseline. This efficacy outperformed the most advanced competitor, Resmetirom (MGL-3196: -8.2 U/L), which has already reached Phase III. Regulatory approvals have been obtained in both the U.S. (IND133807) and Taiwan (No. 1066003042), with plans to conduct a double-blind Phase IIa trial (80 subjects) and a multinational, multicenter Phase IIb trial (300 subjects) to further validate safety and long-term efficacy.

2. Non-invasive biomarker monitoring
A proprietary GSP-based non-invasive diagnostic method is applied to monitor treatment response. Enables more accurate patient stratification and efficacy evaluation without the need for liver biopsy.

3. Dual Product Line Strategy
Sinew Pharma is simultaneously developing multiple product line for enhancing clinical success probability and establishing a competitive lead. As a first-in-class therapy, this is the world’s first multi-target, multi-mechanism drug for MASH, with unique clinical value and market positioning.

4. Proven Safety Through Active Metabolite Experience
The active metabolite of the compound has extensive prior human use experience, supporting an overall favorable safety profile.

5. Optimized Pharmacodynamics
The compound is designed to balance onset of action with sustained therapeutic effect, ensuring both efficacy and patient convenience.

6. Multi-Pathway Disease Modulation
SNP-610 simultaneously addresses multiple pathogenic mechanisms of MASH—including fat accumulation, inflammation, and fibrosis—providing synergistic therapeutic effects and improved disease modulation.