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Sagimet's Denifanstat Advances to Phase 3 for MASH Following FDA Interactions

• Sagimet Biosciences has completed end-of-Phase 2 interactions with the FDA, clearing the path for Phase 3 trials of denifanstat in MASH. • The Phase 3 program includes two trials, FASCINATE-3 for F2/F3 MASH patients and FASCINIT for MASLD/MASH patients, with over 1,800 participants. • Denifanstat, a FASN inhibitor, targets key drivers of liver injury: fat accumulation, inflammation, and fibrosis, addressing a significant unmet need. • The FDA supports Sagimet's strategy to conduct two Phase 3 trials to assess the safety and efficacy of denifanstat in F2/F3 MASH.

Sagimet Biosciences Inc. (Nasdaq: SGMT) announced the successful completion of end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA) regarding the development of denifanstat for metabolic-dysfunction associated steatohepatitis (MASH). This paves the way for the initiation of a Phase 3 program by the end of 2024.
The planned Phase 3 program will consist of two double-blind, placebo-controlled, multicenter registrational trials: FASCINATE-3, focusing on patients with F2/F3 (non-cirrhotic) MASH, and FASCINIT, targeting patients with suspected or confirmed metabolic dysfunction-associated steatotic liver disease (MASLD)/MASH.
Dave Happel, Chief Executive Officer of Sagimet, stated, "Following the recent Breakthrough Therapy designation for denifanstat for treatment of non-cirrhotic MASH, we are pleased with the outcome of our end-of-Phase 2 interactions with the FDA and are appreciative of the agency’s support and guidance on our Phase 3 program for denifanstat in MASH."

Trial Design and Endpoints

The FASCINATE-3 trial will evaluate the efficacy and safety of denifanstat in patients with F2/F3 MASH, using liver biopsy and 4.5-year clinical outcomes as primary endpoints. The FASCINIT trial will assess the safety and tolerability of denifanstat in patients with MASLD/MASH, with non-invasive biomarkers being evaluated as secondary endpoints and no end-of-treatment liver biopsy planned. The Phase 3 program is designed to include a minimum of 1,800 patients exposed to denifanstat.

About MASH

Metabolic-dysfunction associated steatohepatitis (MASH) is a progressive liver disease affecting an estimated 115 million people worldwide. There is only one recently approved treatment in the United States and no currently approved treatments in Europe. MASH is characterized by fat accumulation, inflammation, and fibrosis in the liver.

Denifanstat: A FASN Inhibitor

Denifanstat is an oral, once-daily, selective fatty acid synthase (FASN) inhibitor developed by Sagimet. It is designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. A Phase 2b clinical trial of denifanstat in MASH, FASCINATE-2, demonstrated positive results using liver biopsy-based primary endpoints.
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Sagimet's Denifanstat Advances to Phase III Trials for MASH Treatment

Sagimet Biosciences' denifanstat, a FASN inhibitor, progresses to Phase III trials for metabolic dysfunction-associated steatohepatitis (MASH) after FDA support.
The Phase III program includes two double-blind, placebo-controlled multicenter trials, FASCINATE-3 and FASCINIT, aiming to enroll a minimum of 1,800 patients.

Sagimet's Denifanstat Advances to Phase III Trials for MASH Treatment

Sagimet Biosciences' denifanstat, a selective fatty acid synthase (FASN) inhibitor, has advanced to Phase III trials for metabolic dysfunction-associated steatohepatitis (MASH).
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Sagimet's Denifanstat Receives FDA Breakthrough Therapy Designation for MASH

Sagimet Biosciences' denifanstat has received Breakthrough Therapy Designation from the FDA for treating noncirrhotic MASH with moderate to advanced liver fibrosis.
The designation was supported by Phase 2b FASCINATE-2 study data, which demonstrated statistically significant improvements in MASH resolution and fibrosis reduction.

Reference News

[1]
Sagimet Biosciences Announces Successful Completion of End-of-Phase 2 Interactions with ...
morningstar.com · Oct 29, 2024

Sagimet Biosciences plans two Phase 3 trials, FASCINATE-3 and FASCINIT, to evaluate denifanstat's safety and efficacy in...

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