Sagimet’s Denifanstat Gains the US FDA’s Breakthrough Therapy Designation to Treat Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Shots:
- The US FDA has granted BTD to denifanstat for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with mod. to advanced liver fibrosis, based on the data from P-IIb (FASCINATE-2) study
- Study showed improved 1EPs of MASH resolution without fibrosis worsening with ≥2-point reduction in NAFLD Activity Score (NAS) & a ≥2-point NAS reduction without fibrosis worsening. It also depicted improved fibrosis by ≥1 stage without MASH worsening and with more patients achieving ≥30% MRI-PDFF fat reduction
- The analysis in the ITT population showed significant results on primary & secondary liver biopsy endpoints. It was well tolerated, and its P-III study is planned in YE’24
Ref: Sagimet | Image: Sagimet
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
