Why Is Alzheimer's-Focused Longeveron Stock Trading Higher On Monday?
Why Is Alzheimer's-Focused Longeveron Stock Trading Higher On Monday?
On Sunday, Longeveron Inc (NASDAQ:LGVN) presented Phase 2a clinical trial data and biomarker results at the Alzheimer's Association International Conference (AAIC).
上周日，爱文思控股（NASDAQ:LGVN）在阿尔茨海默病国际协会大会（AAIC）上展示了2a期临床试验数据和生物标志物结果。
The Phase 2a CLEAR MIND trial evaluated 48 patients (36 were treated with Lomecel-B, and 12 received placebo).
CLEAR MIND 试验共有48名患者参与（其中36名接受Lomecel-b治疗，12名接受安慰剂）。
The clinical trial achieved its primary safety and secondary efficacy endpoints, and the study results presented at AAIC 2024 support Lomecel-B's therapeutic potential.
该临床试验已达到其主要安全性和次要疗效终点，AAIC2024年的研究结果支持Lomecel-B的治疗潜力。
Key findings include:
将AD04与心理社会干预相结合，可能有利于改变酒精使用障碍疾病的观念，增加许多原本没有考虑过该治疗的人的需求。
- The established safety profile of Lomecel-B for single and multiple dosing regimens was demonstrated in study data that showed no incidence of hypersensitivity, infusion-related reactions, and no cases of amyloid-related imaging abnormalities (ARIA).
- Patients treated with Lomecel-B showed an overall slowing of disease worsening compared to placebo.
- Efficacy results were demonstrated via a change from baseline at week 39 of the trial at prespecified levels using the Composite Alzheimer's Disease Score (CADS), a secondary outcome measure that combines information across cognitive, functional capacity, and brain MRI domains.
- Administration of Lomecel-B was associated with slowing cognitive and functional decline.
- There was a statistically significant improvement relative to placebo observed in the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL).
- Lomecel-B minimized the loss in brain volume in areas associated with Alzheimer's Disease, statistically significant for left hippocampal volume relative to placebo. Along with positive changes in brain volumes, there was a 20-30% reduction in left and right ventricular enlargement, respectively.
- Diffusion tensor imaging MRI supports the concept that Lomecel-B can potentially reduce neuroinflammation compared to placebo.
- 研究数据显示，Lomecel-b的单次和多个给药方案都具有已确定的安全性，并且没有超敏反应、输液反应或脑淀粉样蛋白相关成像异常(ARIA)的情况。
- 接受Lomecel-b治疗的患者与接受安慰剂的患者相比，阿兹海默病进展速度整体减缓。
- 通过使用综合阿尔茨海默病评分（CADS），临床试验的39周基线变化达到指定水平，证明了Lomecel-b的疗效结果。CADS是一个次要结果，它结合了认知、功能能力和脑MRI领域的信息。
- Lomecel-b的使用与认知和功能下降减缓相关。
- 针对阿尔茨海默病合作研究活动日常生活(ADCS-ADL)，Lomecel-b相对安慰剂方面呈现出统计学显著性改善。
- Lomecel-b在与阿尔茨海默病相关的脑部区域体积减少上有所改善。其中以左侧海马体积相对安慰剂呈显著性统计差异。除了脑部体积的积极变化外，左右心室扩张分别减少了20-30%。
- 扩散张量成像MRI支持Lomecel-b相对于安慰剂潜在降低神经炎症的概念。
In October last year, Longeveron announced topline results from the Phase 2a trial of its investigational product Lomecel-B for mild Alzheimer's disease.
去年十月，爱文思控股宣布了Lomecel-b用于轻度阿尔茨海默病的试验2a期的头条结果。
The primary endpoint of safety was met based on statistical and medical assessment. One Serious Adverse Event (SAE) was reported on each Lomecel-B treatment group and none on placebo.
安全性的主要终点基于统计和医学评估得以满足。在两组Lomecel-b治疗组中各报告了一个重大不良事件（SAE），而安慰剂组没有人报告。
Earlier this month, the company announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B for mild Alzheimer's Disease.
本月早些时候，该公司宣布FDA授予Lomecel-b用于轻度阿尔茨海默病的再生医学先进疗法（RMAT）认证。
Price Action: LGVN stock is up 22.10% at $4.20 during the premarket session at last check Monday.
上周一盘前交易时LGVN股票涨22.10%，报$4.20。
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Image via Shutterstock
图片来自shutterstock。