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Sagimet Plans Move To Phase III In NASH By Year-End

 
• By Joseph Haas

Sagimet reported positive Phase IIb data for denifanstat in non-alcoholic steatohepatitis that may place the once-daily, oral drug as a serious competitor in a disease that at present has no approved drug therapy.

Fatty liver
Sagimet is looking to take its NASH candidate into Phase III later this year • Source: Shutterstock

Sagimet Biosciences hopes to bring its fatty acid synthase (FASN) inhibitor denifanstat into Phase III development for non-alcoholic steatohepatitis (NASH) during the second half of 2024 after a Phase IIb trial showed the drug can reduce disease activity and fibrosis.

The biotech reported on 22 January that in top-line data from the 168-patient FASCINATE-2 study, denifanstat met the co-primary endpoints measuring disease activity and

Key Takeaways

  • Sagimet’s denifanstat is the only FASN inhibitor in clinical development for NASH and may advance to Phase III later this year.

  • In Phase IIb, the oral drug hit endpoints measuring NASH resolution, disease activity and fibrosis reduction

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