原始来源记录
决策级顶线结果
Biohaven：Opakalim 75 mg 在 IGE 概念验证试验中显示出 3 倍癫痫发作延迟
该新闻稿报告了在特发性全面性癫痫中进行的随机、安慰剂对照的时间-事件研究中获得的积极概念验证数据，以及局灶性癫痫的更新开放标签扩展数据，证实了癫痫控制和明显低于其他 Kv7 激活剂的中枢神经系统不良事件发生率。Biohaven 重申，其两项局灶性癫痫关键性 2/3 期试验中的第一项将于 2026 年下半年公布顶线结果。
关键事实
来源摘录
EX-99.1 2 exhibit991may26thpressrele.htm EX-99.1 Document Exhibit 99.1 Biohaven Reports New Clinical Data in Epilepsy with Opakalim, a Selective Kv7.2/7.3 Activator, Highlighting Seizure Control and Markedly Differentiated Tolerability Profile • In a randomized, placebo-controlled, time-to-event trial in idiopathic generalized epilepsy (IGE), the median time to the second day with a generalized tonic-clonic seizure was 141 days in the opakalim 75 mg once-daily treatment group vs. 47 days in the placebo group, representing a 3-fold prolongation. • In an ongoing open-label extension (OLE) study in focal epilepsy, an updated data analysis shows 54% of patients with focal epilepsy on opakalim 75 mg once-daily achieved a ≥50% reduction in seizure frequency over any consecutive six months of