CNS Disorder-Focused Seelos Therapeutics Plunges To 52-Week Low - Here's Why
CNS Disorder-Focused Seelos Therapeutics Plunges To 52-Week Low - Here's Why
Tuesday, Seelos Therapeutics Inc (NASDAQ:SEEL) provided an update on top-line data of the Phase 2/3 HEALEY ALS Platform trial.
周二，Seelos Therapeutics Inc（纳斯达克股票代码：SEEL）提供了2/3期HEALEY ALS平台试验的最新数据。
The study was designed to evaluate SLS-005 (IV trehalose), a low molecular weight disaccharide that stabilizes misfolded proteins and activates autophagy, in decreasing the slope of the ALS Functional Rating Scale (ALSFRS-R) and separation from placebo in Function and Mortality in an all-comers population of Persons with ALS (PALS).
该研究旨在评估 SLS-005（静脉注射海藻糖），一种稳定错误折叠的蛋白质并激活自噬的低分子量二糖，它在降低肌萎缩性侧索硬化症功能评级量表（ALSFRS-R）的斜率以及在功能和死亡率方面与安慰剂的分离（ALSFRS-R）在功能和死亡率方面与安慰剂的分离情况。
The company said that while the study did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set (FAS), it showed a 13% improvement in Function and Mortality with an 88% success probability (versus the pre-specified 98%), a potential signal of efficacy in a pre-specified subgroup (ERF).
该公司表示，尽管该研究在全分析集（FAS）的主要和次要终点中没有达到统计学意义，但它显示功能和死亡率提高了13％，成功概率为88％（而预先规定的98％），这是预先指定的亚组（ERF）的潜在疗效信号。
In the pre-specified subgroup of PALS treated with SLS-005, without Amylyx Pharmaceuticals Inc (NASDAQ:AMLX) Relyvrio, the top-line data favored SLS-005 versus placebo in efficacy measures in the Efficacy RELYVRIO Free (ERF) data set (n=130), including:
在未使用 Amylyx Pharmicals Inc（纳斯达克股票代码：AMLX）Relyvrio 的预先指定的使用 SLS-005 治疗的 PALS 子组中，在疗效 RELYVRIO Free（ERF）数据集（n=130）的疗效指标中，顶级数据偏向于 SLS-005 而不是安慰剂，包括：
- 22% improvement in the slope of change in ALSFRS-R assessment adjusted for mortality, with an 89% success probability, at 24 weeks.
- The rate of decline in ALSFRS-R slope (points per month) also favored the SLS-005 treatment group versus placebo over six months (-0.80 and -1.07 points per month, respectively).
- 25% slowing of Slow Vital Capacity (SVC) decline versus placebo (-11.5% for SLS-005 and -15.4% for placebo) at 24 weeks.
- 经死亡率调整后，在24周时，ALSFRS-R评估的变化斜率提高了22％，成功概率为89％。
- 与安慰剂相比，ALSFRS-R斜率（每月分数）的下降率（每月分别为-0.80点和-1.07点）也对 SLS-005 治疗组有利。
- 24 周时，与安慰剂相比，慢活量 (SVC) 下降速度减慢 25%（SLS-005 为 -11.5%，安慰剂为 -15.4%）。
Seelos awaits receiving full data sets and it plans to run additional analyses, including biomarkers of neurodegeneration, neurofilament light chain, exploratory efficacy results, subgroups, and post-hoc analyses.
Seelos正在等待收到完整的数据集，并计划进行更多分析，包括神经变性的生物标志物、神经丝轻链、探索性疗效结果、亚组和事后分析。
SLS-005 was generally well-tolerated and comparable to placebo in safety.
SLS-005 的耐受性总体良好，在安全性上可与安慰剂相媲美。
Price Action: SEEL shares are down 54.2% at $0.42 on the last check Tuesday.
价格走势：SEEL股价在周二的最后一次检查中下跌54.2％，至0.42美元。
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