一次情報の記録
決定級トップライン結果
Amylyx: LUCIDITY第3相試験でavexitideがPBHに対して肯定的なトップライン結果
LUCIDITYはFDA合意の主要評価項目を達成し、Level 2/3低血糖イベントを55%減少させました（p=0.000003）。すべての副次評価項目も達成。Amylyxは2026年末までにavexitideのNDAを提出予定です。
主要事実
出典の抜粋
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