原始来源记录
决策级顶线结果
Definium 报告 DT120 ODT 治疗 GAD 的 Panorama 3 期试验正面顶线结果
Panorama 试验达到主要终点及所有关键次要终点，显示第 12 周时安慰剂校正的 HAM-A 评分降低 5.1 分（p<0.0001，d=0.64），具有统计学意义。这是 DT120 ODT 获得的第三项正面 3 期结果，也是 GAD 适应症的第二项正面 3 期结果，进一步充实了计划于 2026 年第 4 季度召开的 pre-NDA 会议及 2027 年上半年 NDA 申报的监管资料包。
关键事实
- 申报时间
- 2026年9月14日 12:02
- 事件
- 顶线结果
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- cohen d
- 0.64
- response rate
- 32% vs 14%
- ham a ls mean change
- -9.8 vs -4.7
- placebo adjusted difference
- -5.1 (p<0.0001)
来源摘录
EX-99.1 2 tm2625365d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Definium Therapeutics Announces Positive Topline Results from Phase 3 Panorama Study of DT120 ODT in Generalized Anxiety Disorder Study met primary and all key secondary efficacy endpoints; Panorama is the second positive Phase 3 trial for DT120 ODT in GAD and the third positive Phase 3 trial for DT120 ODT Participants receiving DT120 ODT 100 µg achieved a statistically significant reduction in Hamilton Anxiety Rating Scale (HAM-A) score, with a placebo-adjusted change of 5.1 points from baseline at Week 12 (p<0.0001, Cohen’s d=0.64) DT120 ODT 100 µg was generally well tolerated, with a safety profile consistent with prior clinical experience Pre-NDA meeting scheduled in 4Q 2026; NDA filing anticipated in 1H 2027 Company to