原始来源记录
决策级顶线结果
Viridian：REVEAL-1 III期积极顶线结果显示elegrobart治疗活动性TED有效
REVEAL-1达到主要终点，即第24周眼球突出应答率在Q4W和Q8W给药方案下均具有高度统计学意义。该试验还显示出具有临床意义的复视缓解以及总体耐受性良好的安全性特征，使elegrobart有望在2027年第一季度提交BLA。
关键事实
- 申报时间
- 2026年3月30日 11:50
- 事件
- 顶线结果
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- Q4W听力损害
- 安慰剂校正4.1%
- Q8W听力损害
- 安慰剂校正8.8%
- Q4W复视缓解率
- 61% vs 安慰剂38%（p = 0.0118）
- Q4W眼球突出缓解率
- 50% vs 安慰剂15%（p < 0.0001）
- Q8W眼球突出缓解率
- 54% vs 安慰剂15%（p < 0.0001）
来源摘录
EX-99.1 2 d27955dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Viridian Therapeutics Announces Positive Topline Results from Elegrobart Phase 3 REVEAL-1 Clinical Trial in Active Thyroid Eye Disease - REVEAL-1 met the primary endpoint of Q4W proptosis responder rate (PRR) with a highly statistically significant treatment effect - - Elegrobart Q4W and Q8W achieved clinically meaningful 54% and 63% PRR versus 18% placebo at week 24 - - Complete resolution of diplopia in 51% of patients treated Q4W versus 16% placebo at week 24 - - Elegrobart was generally well tolerated in both dose groups with low rates of hearing impairment - - REVEAL-2, a phase 3 clinical trial evaluating elegrobart in patients with chronic TED, is on track for topline readout in Q2 2026; BLA submission anticipated in Q1 2