原始出處紀錄
決策級主要結果 (Topline)
Amylyx：LUCIDITY 第三期試驗正面頂線結果顯示 avexitide 治療 PBH 有效
LUCIDITY 達到 FDA 同意的主要終點，Level 2/3 低血糖事件減少 55%（p=0.000003），並達成所有次要終點。Amylyx 計劃於 2026 年底前提交 avexitide 的 NDA。
關鍵事實
- 申報時間
- 2026年8月18日 上午11:09
- 事件
- 主要結果 (Topline)
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
- P 值
- 0.000003
- 降低幅度
- 55%
- 參與者
- 78 人
來源摘錄
EX-99.1 2 d180533dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Amylyx Pharmaceuticals Announces Positive Topline Results from Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia • LUCIDITY met FDA-agreed-upon primary endpoint; avexitide demonstrated a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003) • LUCIDITY met all secondary endpoints showing consistent, highly statistically significant, and clinically meaningful reductions in Level 2 by self-monitoring of blood glucose (SMBG), Level 2 by CGM, and Level 3 hypoglycemic events • Avexitide was generally well-tolerated with a favorable safety profile • Amylyx plans to submit an NDA for avexitide with the FDA by year-end; avexitide has Breakthrough T