Omeros Antibody Improves Overall Survival In Rare Complication After Stem Cell Transplant
Omeros Antibody Improves Overall Survival In Rare Complication After Stem Cell Transplant
The analysis compared overall survival in the 28 TA-TMA patients in OMS721-TMA-001, Omeros' previously conducted pivotal trial for narsoplimab in TA-TMA, to that of more than 100 similarly high-risk TA-TMA patients in an external control registry of HSCT patients who did not receive narsoplimab treatment.On Thursday, Omeros Corporation (NASDAQ:OMER) announced that an independent statistical group has completed the primary statistical analysis agreed with the FDA for narsoplimab.
上周四，奥麦罗制药（纳斯达克：OMER）宣布，一个独立统计小组已完成与FDA达成一致的narsoplimab的主要统计分析。
Omeros is a first-in-class monoclonal antibody that inhibits the lectin pathway of complement in hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
奥麦罗制药是一种首创单克隆抗体，可抑制造血干细胞移植相关血栓性微血管病（TA-TMA）中的凝集素通路。
TA-TMA is a complication in adult and pediatric hematopoietic stem cell transplantation (HSCT).
TA-TMA是成人和儿童造血干细胞移植（HSCT）中的一种并发症。
The analysis compared overall survival in the 28 TA-TMA patients in OMS721-TMA-001, Omeros' previously conducted pivotal trial for narsoplimab in TA-TMA, to that of more than 100 similarly high-risk TA-TMA patients in an external control registry of HSCT patients who did not receive narsoplimab treatment.
该分析比较了28名TA-TMA患者在OMS721-TMA-001试验中的整体生存率，奥麦罗制药此前进行的narsoplimab在TA-TMA中的关键试验，超过100名未接受narsoplimab治疗的高风险TA-TMA患者在外部对照注册中的整体生存率。
Narsoplimab met its primary endpoint, with OMS721-TMA-001 patients demonstrating clinically meaningful and statistically significant superiority in overall survival – a hazard ratio of 0.32 compared to the TA-TMA registry patients.
narsoplimab达到了其主要终点，OMS721-TMA-001的患者在整体生存率上表现出临床意义和统计学显著的优越性——与TA-TMA注册患者相比，风险比为0.32。
Late last month, Omeros announced that it had received FDA's recommendations on the statistical analysis plan (SAP) for the primary analysis comparing overall survival from the time of first dosing in the 28 narsoplimab-treated TA-TMA patients in the pivotal trial OMS721-TMA-001 to overall survival, adjusted for immortal time bias, of the more than 100 TA-TMA patients in the external control registry, none of whom received narsoplimab.
上个月底，奥麦罗制药宣布已收到FDA关于主要分析的统计分析计划（SAP）的建议，该分析比较了在关键试验OMS721-TMA-001中28名接受narsoplimab治疗的TA-TMA患者的生存率，以及在外部对照注册中超过100名未接受narsoplimab的TA-TMA患者的生存率，已对不朽时间偏倚进行了调整。
To date, narsoplimab has been well tolerated and has shown no safety signal of concern across all its clinical trials in various indications.
迄今为止，narsoplimab的耐受性良好，在各类适应症的所有临床试验中均未出现安全性担忧的信号。
Given the primary analysis results, we will resubmit the narsoplimab BLA for TA-TMA as quickly as possible, followed by our planned submission of the corresponding European marketing authorization application in the second quarter of 2025.
鉴于主要分析结果，我们将尽快重新提交narsoplimab的TA-TMA生物制剂许可申请，随后计划在2025年第二季度提交相应的欧洲市场授权申请。
Additional sensitivity and other analyses are pending and should be available over the next few weeks.
额外的敏感性和其他分析仍在进行中，预计在接下来的几周内可以获得。
Price Action: OMER stock is up 54.8% at $11.55 at last check Thursday.
价格走势：奥麦罗制药股票在周四最后一次检查时上涨了54.8%，报11.55美元。
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