Sagimet:FASCINATE-2 2b期denifanstat治疗MASH的数据

该8-K附件展示了denifanstat在F2/F3 MASH中的FASCINATE-2 Phase 2b完整顶线活检结果，确认两个主要终点均达到统计学意义（NAS改善≥2且无纤维化恶化：38% vs 16%；MASH缓解 + NAS改善≥2：26% vs 11%），以及关键次要终点纤维化改善≥1期且MASH无恶化（41% vs 18%）。这些数据此前已在2024年第一季度公布，现正式披露于SEC备案文件，确立了Phase 3推进的监管路径。

关键事实

申报时间: 2025年10月23日 20:06
事件: 顶线结果
方向: 积极
公司: SGMTSagimet Biosciences
资产: denifanstat
来源: SEC 8-K
可信度: 有来源
2b期MASH缓解率: 26%对比11%
2b期NAS改善率: 38%对比16%
2b期纤维化改善率: 41%对比18%

来源摘录

EX-99.1 2 tm2529317d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Targeting MetabolicDysfunction with Novel Therapies to Treat MASH, Acne&Cancer October 2025 October 2025 2 Forward-Looking Statements and Disclaimer This presentation contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this document, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding possible or assumed future results of operations, business strategies, research and development plans, regulatory activities, the presentation of data from clinical trials, Sagimet’s clinical development

SEC 8-K