With shares rising 8.50% to $3.00 as of the most recent check, Sagimet Biosciences Inc. (NASDAQ: SGMT) is witnessing a noteworthy increase in its stock price today. That followed SGMT’s announcement that its principal medicine, denifanstat, has been designated as a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA). The purpose of this medication is to treat moderate to advanced liver fibrosis in patients with noncirrhotic metabolic dysfunction-associated steatohepatitis or MASH.
FDA Grants Breakthrough Therapy Designation to Denifanstat
The FDA’s designation of denifanstat as a Breakthrough Therapy highlights the growing global prevalence of MASH and the urgent demand for innovative treatments. Denifanstat stands out as the sole fat synthesis inhibitor that targets the three critical factors driving MASH: fat accumulation, inflammation, and fibrosis. As a result, it holds tremendous potential to become a critical treatment alternative for people affected by this ailment.
Importance of the Designation of Breakthrough Therapy
Based on early clinical data, medications that target critical or life-threatening illnesses and show a significant improvement over current therapy are eligible for the Breakthrough Therapy designation. Pharmaceuticals that are granted this classification have several advantages, including accelerated development procedures, extensive FDA advice, and increased organizational commitment from senior FDA administrators. This recognition places denifanstat in a favorable position for accelerated development.
Positive Phase 2b Clinical Trial Results Support Designation
Denifanstat’s Breakthrough Therapy designation is supported by promising data from the Phase 2b FASCINATE-2 clinical trial. In this trial, denifanstat significantly outperformed placebo in resolving MASH without worsening fibrosis, achieving a two-point reduction in the Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score. Additionally, patients treated with denifanstat demonstrated improvements in liver fibrosis and fat reduction, as measured by MRI-derived proton density fat fraction (MRI-PDFF).
Next Steps in Development
Following the positive outcomes from the Phase 2b trial, Sagimet plans to initiate a Phase 3 clinical program for denifanstat in late 2024. The company is optimistic about its potential to advance the treatment landscape for MASH, with denifanstat showing both efficacy and tolerability.
