原始来源记录
决策级顶线结果
Tenax LEVEL 3期试验未达到TNX-103在PH-HFpEF中的主要6MWD终点
口服左西孟旦（TNX-103）在PH-HFpEF中的LEVEL 3期试验未达到6分钟步行距离改善相对于安慰剂的主要终点。预先指定的亚组分析显示，基线6MWD低于试验中位数333米的患者有统计学意义的26.3米获益，同时NT-proBNP降低49%，右心室收缩压降低3.5 mmHg。Tenax计划请求与FDA召开C型会议，讨论注册项目的富集策略。
关键事实
- 申报时间
- 2026年8月10日 11:19
- 事件
- 顶线结果
- 方向
- 消极
- 来源
- SEC 8-K
- 可信度
- 有来源
- RVSP降低
- 3.5 mmHg vs 安慰剂（名义p=0.0045）
- 6MWD最小二乘均值差
- 3.5米（p=0.63）
- 6MWD亚组333m
- 26.3米（95% CI 6.0, 46.7；名义p=0.0112）
- NT-proBNP降低
- 49% vs 安慰剂（名义p<0.0001）
来源摘录
EX-99.1 2 d115761dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Tenax Therapeutics Announces Topline Results from Phase 3 LEVEL Clinical Trial of TNX-103 in Patients with PH-HFpEF TNX-103 did not meet statistical significance on the primary endpoint of improvement in 6-minute walk distance versus placebo In prespecified exploratory analyses in the overall trial population, treatment with TNX-103 resulted in a 49% greater reduction in NT-proBNP compared to placebo (nominal p<0.0001) and a reduction of 3.5 mmHg in right ventricular systolic pressure compared to placebo (nominal p=0.0045) In a prespecified analysis, patients with a baseline 6-minute walk distance below the trial median of 333 meters showed a 26.3-meter improvement compared to placebo (95% CI 6.0, 46.7; nominal p=0.0112) Compan