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.
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).
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).
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:
- 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.
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.
SLS-005 was generally well-tolerated and comparable to placebo in safety.
Price Action: SEEL shares are down 54.2% at $0.42 on the last check Tuesday.
Photo via Shutterstock
Tuesday, Seelos Therapeutics Inc (NASDAQ:SEEL) provided an update on top-line data of the Phase 2/3 HEALEY ALS Platform trial.
週二，Seelos Therapeutics Inc（納斯達克股票代碼：SEEL）提供了2/3期HEALEY ALS平台試驗的最新數據。
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).
該研究旨在評估 SLS-005（靜脈注射海藻糖），一種穩定錯誤摺疊的蛋白質並激活自噬的低分子量二糖，它在降低肌萎縮性側索硬化症功能評級量表（ALSFRS-R）的斜率以及在功能和死亡率方面與安慰劑的分離（ALSFRS-R）在功能和死亡率方面與安慰劑的分離情況。
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).
該公司表示，儘管該研究在全分析集（FAS）的主要和次要終點中沒有達到統計學意義，但它顯示功能和死亡率提高了13％，成功概率爲88％（而預先規定的98％），這是預先指定的亞組（ERF）的潛在療效信號。
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（納斯達克股票代碼：AMLX）Relyvrio 的預先指定的使用 SLS-005 治療的 PALS 子組中，在療效 RELYVRIO Free（ERF）數據集（n=130）的療效指標中，頂級數據偏向於 SLS-005 而不是安慰劑，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.
- 經死亡率調整後，在24周時，ALSFRS-R評估的變化斜率提高了22％，成功概率爲89％。
- 與安慰劑相比，ALSFRS-R斜率（每月分數）的下降率（每月分別爲-0.80點和-1.07點）也對 SLS-005 治療組有利。
- 24 周時，與安慰劑相比，慢活量 (SVC) 下降速度減慢 25%（SLS-005 爲 -11.5%，安慰劑爲 -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數據集，並計劃進行更多分析，包括神經變性的生物標誌物、神經絲輕鏈、探索性療效結果、亞組和事後分析。
SLS-005 was generally well-tolerated and comparable to placebo in safety.
SLS-005 的耐受性總體良好，在安全性上可與安慰劑相媲美。
Price Action: SEEL shares are down 54.2% at $0.42 on the last check Tuesday.
價格走勢：SEEL股價在週二的最後一次檢查中下跌54.2％，至0.42美元。
Photo via Shutterstock
照片來自 Shutterstock
譯文內容由第三人軟體翻譯。
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