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Denifanstat May Expand Treatment Options for People with Fatty Liver Disease
Learn about denifanstat, a medication that may soon become a treatment option for people living with fatty liver disease.
On March 14, 2024, Rezdiffra (resmetirom) became the first drug ever approved by the U.S. Food and Drug Administration (FDA) to treat patients who have fatty liver disease with moderate to advanced fibrosis. (1) Now, another medication may soon become a treatment option. It’s called denifanstat and has shown promising results.
What Is Denifanstat?
Denifanstat is a fat synthesis inhibitor. In simple terms, this type of drug prevents fatty acids from forming, which is what makes it beneficial for fatty liver disease — a condition characterized by a buildup of fat in the liver.
In an October 11, 2024, news release, Dave Happel, the CEO of Sagimet Biosciences (the maker of denifanstat), shared the results of a clinical trial involving patients with metabolic-dysfunction associated steatohepatitis (MASH). Happel explained that denifanstat helped improve MASH in patients with advanced fibrosis in three ways: (2)
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- By decreasing liver fat
- By reducing liver inflammation
- By improving liver fibrosis
Research Findings on Denifanstat for MASH
Formal results of Sagimet’s trial were published online by The Lancet Gastroenterology & Hepatology. (3) This was a phase 2b clinical trial, and phase 2 research trials are used to determine an experimental drug’s effectiveness for a specific condition, as well as to identify the dosage level and frequency needed to achieve a therapeutic effect. (4)
Research on denifanstat was conducted in 100 clinical sites across three different countries and involved 168 patients with confirmed MASH and stage F2 or F3 liver fibrosis. Some study participants received the drug denifanstat for 52 weeks and the rest received a placebo or sham treatment.
What did researchers find?
- At the end of the study, two times as many participants receiving the actual drug had a 2-point or greater improvement in their disease without a worsening of fibrosis than those receiving the placebo, at 38% versus 16% respectively.
- Forty-one percent of the denifanstat group also improved their fibrosis by at least one stage compared to only 18% of the placebo group.
- The active drug group also experienced greater reductions in their liver fat and inflammation-related enzymes.
Breakthrough Therapy Designation
Results of this clinical trial were presented to the FDA and, as a result, denifanstat was granted the Breakthrough Therapy designation. (5) The FDA shares that this designation is designed to speed up drug development and review when initial evidence suggests that the drug may provide “substantial improvement over available therapy” with regard to specific endpoints related to serious symptoms and/or mortality. (6)
While more research is needed, this trial suggests that progress is being made toward finding more treatment options for people living with advanced fatty liver disease. We’ll keep you updated on how this research goes and if denifanstat becomes a treatment option.
(1) U.S. Food and Drug Administration. (2024, March 14). FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease. Retrieved November 07, 2024, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease
(2) Sagimet Biosciences. (2024, October 11). Sagimet Biosciences Announces Publication of Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 MASH in The Lancet Gastroenterology & Hepatology. Retrieved November 07, 2024, from https://ir.sagimet.com/news-releases/news-release-details/sagimet-biosciences-announces-publication-results-phase-2b
(3) Loomba, R., Bedossa, P., Grimmer, K., et al. (2024, December). Denifanstat for the treatment of metabolic dysfunction-associated steatohepatitis: a multicentre, double-blind, randomized, placebo-controlled, phase 2b trial. The Lancet Gastroenterology & Hepatology. doi:10.1016/S2468-1253(24)00246-2
(4) University of Cincinnati College of Medicine. (n.d.). Clinical Trials Phases Defined. Retrieved November 07, 2024, from https://med.uc.edu/depart/psychiatry/research/clinical-research/crm/trial-phases-1-2-3-defined
(5) Sagimet Biosciences. (2024, October 01). Sagimet Receives FDA Breakthrough Therapy Designation for Denifanstat in MASH. Retrieved November 07, 2024, from https://ir.sagimet.com/news-releases/news-release-details/sagimet-receives-fda-breakthrough-therapy-designation
(6) U.S. Food and Drug Administration. (2018, January 04). Breakthrough Therapy. Retrieved November 07, 2024, from https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
About the Author
Christina M. DeBusk, BS is an accomplished health writer and editor with a passion for natural wellness, disease prevention, and holistic treatment options. With certifications as a Nutrition Specialist, Personal Trainer, and Transformation Specialist, Christina brings a wealth of expertise to her writing. Her articles have been featured in numerous health-related publications both online and in print including Woman’s Day, Massage Magazine, Country Living, Chiropractic Economics, and Very Well Mind, empowering readers to lead healthier lives through informed choices and natural solutions.
