1차 출처 기록
결정급탑라인 결과
Amylyx: LUCIDITY 3상 탑라인, PBH에서 avexitide 양성 결과
LUCIDITY는 FDA가 합의한 1차 평가변수를 충족했으며, Level 2/3 저혈당 사건을 55% 감소시켰습니다(p=0.000003). 모든 2차 평가변수도 충족했습니다. Amylyx는 2026년 말까지 avexitide의 NDA를 제출할 계획입니다.
핵심 사실
출처 발췌
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