Denifanstat

Ascletis Pharma completes enrollment of 480 patients for Phase III trial of ASC40 oral tablet for moderate to severe acne, with topline results expected in Q2 2025.

Ascletis Pharma completes enrollment of 480 patients for Phase III trial of ASC40 oral tablet for moderate to severe acne, with topline results expected in Q2 2025.

Sagimet Biosciences plans to launch two Phase 3 trials for its oral therapy denifanstat in people with metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), with trials expected to start by year-end. Denifanstat, designed to block the fatty acid synthase enzyme, aims to reduce liver fat buildup and improve liver health. The trials, supported by the FDA, will assess safety and efficacy in MASLD/MASH patients.

Sagimet Biosciences advances denifanstat, an FASN inhibitor, into Phase III trials for treating MASH, with FDA support. The Phase III program includes FASCINATE-3 and FASCINIT trials, aiming to assess efficacy and safety in MASH and MASLD patients.

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.