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).
上週日，愛文思控股（NASDAQ:LGVN）在阿爾茨海默病國際協會大會（AAIC）上展示了2a期臨床試驗數據和生物標誌物結果。
The Phase 2a CLEAR MIND trial evaluated 48 patients (36 were treated with Lomecel-B, and 12 received placebo).
CLEAR MIND 試驗共有48名患者參與（其中36名接受Lomecel-b治療，12名接受安慰劑）。
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.
該臨床試驗已達到其主要安全性和次要療效終點，AAIC2024年的研究結果支持Lomecel-B的治療潛力。
Key findings include:
將AD04與心理社會干預相結合，可能有利於改變酒精使用障礙疾病的觀念，增加許多原本沒有考慮過該治療的人的需求。
- 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.
- 研究數據顯示，Lomecel-b的單次和多個給藥方案都具有已確定的安全性，並且沒有超敏反應、輸液反應或腦澱粉樣蛋白相關成像異常(ARIA)的情況。
- 接受Lomecel-b治療的患者與接受安慰劑的患者相比，阿茲海默病進展速度整體減緩。
- 通過使用綜合阿爾茨海默病評分（CADS），臨床試驗的39周基線變化達到指定水平，證明了Lomecel-b的療效結果。CADS是一個次要結果，它結合了認知、功能能力和腦MRI領域的信息。
- Lomecel-b的使用與認知和功能下降減緩相關。
- 針對阿爾茨海默病合作研究活動日常生活(ADCS-ADL)，Lomecel-b相對安慰劑方面呈現出統計學顯著性改善。
- Lomecel-b在與阿爾茨海默病相關的腦部區域體積減少上有所改善。其中以左側海馬體積相對安慰劑呈顯著性統計差異。除了腦部體積的積極變化外，左右心室擴張分別減少了20-30%。
- 擴散張量成像MRI支持Lomecel-b相對於安慰劑潛在降低神經炎症的概念。
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，愛文思控股宣佈了Lomecel-b用於輕度阿爾茨海默病的試驗2a期的頭條結果。
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.
安全性的主要終點基於統計和醫學評估得以滿足。在兩組Lomecel-b治療組中各報告了一個重大不良事件（SAE），而安慰劑組沒有人報告。
Earlier this month, the company announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B for mild Alzheimer's Disease.
本月早些時候，該公司宣佈FDA授予Lomecel-b用於輕度阿爾茨海默病的再生醫學先進療法（RMAT）認證。
Price Action: LGVN stock is up 22.10% at $4.20 during the premarket session at last check Monday.
上週一盤前交易時LGVN股票漲22.10%，報$4.20。
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Image via Shutterstock
圖片來自shutterstock。