Denifanstat

Sagimet Biosciences plans two Phase 3 trials, FASCINATE-3 and FASCINIT, to evaluate denifanstat's safety and efficacy in MASH and MASLD patients, with initiation expected by end of 2024.

Several Phase III trials for MASH, including FGF21 analogues like efruxifermin and pegozafermin, FASN inhibitor denifanstat, and GLP-1 receptor agonists like semaglutide, are underway, aiming to revolutionize MASH treatment. Noninvasive tests (NITs) are gaining traction as alternatives to liver biopsies, potentially accelerating trial processes. These developments highlight diverse therapeutic approaches to address MASH's multifactorial nature, with combination therapies offering comprehensive management strategies.

Denifanstat, an oral FASN inhibitor, showed significant improvements in MASH and fibrosis in a phase II trial, with 26% of patients experiencing MASH resolution and 38% improving NAS score without fibrosis worsening. The drug also demonstrated beneficial cardiometabolic effects and was generally well-tolerated, though alopecia was a common side effect. Based on these results, the FDA granted breakthrough therapy designation to denifanstat for MASH treatment.

Denifanstat treatment in Phase 2b FASCINATE-2 trial showed significant improvements in MASH resolution and fibrosis, supporting its advancement to Phase 3 development.

Denifanstat treatment in Phase 2b FASCINATE-2 trial showed significant improvements in MASH resolution and fibrosis, supporting its advancement to Phase 3 development.

The phase 2b FASCINATE-2 trial of denifanstat in MASH patients with stage 2 or 3 fibrosis showed significant improvements in disease activity, MASH resolution, and fibrosis. Published in The Lancet Gastroenterology and Hepatology, the study demonstrated denifanstat's effectiveness on primary endpoints: MASH resolution without fibrosis worsening and NAS reduction without fibrosis worsening. Denifanstat, an oral FASN inhibitor, targets fat accumulation, inflammation, and fibrosis, key drivers of MASH, and received FDA Breakthrough Therapy Designation for noncirrhotic MASH with moderate to advanced fibrosis.

The FDA granted breakthrough therapy designation to Boehringer Ingelheim’s survodutide for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate or advanced fibrosis. Two global phase 3 trials, LIVERAGE and LIVERAGE-Cirrhosis, will assess survodutide’s safety and efficacy. The trials aim to determine if survodutide can improve MASH and fibrosis, and reduce the risk of end-stage liver disease.

The FDA granted breakthrough therapy designation to Sagimet Biosciences' denifanstat, an oral therapy for MASH patients with moderate to advanced liver fibrosis. Denifanstat, which blocks a fat-producing protein in the liver, showed superiority to placebo in resolving MASH without worsening fibrosis in Phase 2b trials. Sagimet plans to launch a Phase 3 trial by year's end.

FDA grants breakthrough status to Sagimet’s denifanstat for treating MASH with fibrosis, based on positive phase 2b FASCINATE-2 trial data showing significant improvements in liver histology and fibrosis.

The FDA granted breakthrough therapy designation to Sagimet Biosciences' denifanstat for treating noncirrhotic MASH with moderate to advanced liver fibrosis, based on positive phase 2b FASCINATE-2 trial results showing 36% disease resolution and 41% fibrosis improvement with denifanstat vs. 13% and 18% with placebo, respectively.