Alector/AbbVie合作的阿尔茨海默氏症药物在中期研究中令人失望；Alector裁员17%-动脉网

Alector/AbbVie-Partnered Alzheimer's Drug Disappoints In Mid-Stage Study; Alector Lays Off 17% Of Workforce

benzinga 等信源发布 2024-11-26 10:29

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On Monday, Alector, Inc. ALEC released results from the INVOKE-2 Phase 2 trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD).

周一，Alector，Inc.ALEC发布了INVOKE-2 2期临床试验的结果，该试验评估了AL002在减缓早期阿尔茨海默病（AD）患者疾病进展方面的安全性和有效性。

AL002 failed to meet the primary endpoint of slowing Alzheimer’s clinical progression as measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB).

AL002未能达到通过临床痴呆评定框总和（CDR-SB）测量的减缓阿尔茨海默氏病临床进展的主要终点。

Also, no treatment effects favored AL002 on secondary clinical and functional endpoints.

此外，没有治疗效果有利于AL002的次要临床和功能终点。

The company says treatment with AL002 resulted in sustained target engagement and pharmacodynamic responses indicative of microglial activation.

该公司表示，AL002治疗可导致持续的靶向参与和指示小胶质细胞活化的药效学反应。

Similarly, there were no significant effects on Alzheimer’s fluid biomarkers favoring AL002, and amyloid PET imaging demonstrated no treatment-related reduction of brain amyloid levels.

同样，对有利于AL002的阿尔茨海默氏症液体生物标志物没有显着影响，淀粉样蛋白PET成像显示脑淀粉样蛋白水平没有治疗相关的降低。

As previously reported, INVOKE-2 showed MRI changes resembling amyloid-related imaging abnormalities (ARIA) and infusion-related reactions. ARIA was primarily seen in participants treated with AL002.

如先前报道，INVOKE-2显示出类似于淀粉样蛋白相关成像异常（ARIA）和输注相关反应的MRI变化。ARIA主要见于接受AL002治疗的参与者。

Based on the results, Alector is stopping the long-term extension study.

根据结果，Alector停止了长期扩展研究。

Alector’s focus are progranulin-elevating programs, latozinemab, and AL101/GSK4527226, developed in collaboration with GSK Plc GSK.

Alector的重点是与GSK Plc GSK合作开发的颗粒体蛋白前体提升程序，拉托单抗和AL101/GSK4527226。

Topline data from the pivotal INFRONT-3 Phase 3 trial of latozinemab in frontotemporal dementia with a progranulin gene mutation is expected in late 2025 or early 2026.

预计在2025年末或2026年初，来自关键的INFRONT-3期3期临床试验的拉托单抗治疗额颞叶痴呆伴颗粒蛋白前体基因突变的Topline数据。

PROGRESS-AD Phase 2 trial of AL101/GSK4527226 in early AD reached over one-third of its target enrollment of 282 participants. Alector is also advancing its preclinical candidates aimed at a broad and diverse range of protein and enzyme targets.

AD早期AL101/GSK4527226的PROGRESS-AD 2期试验达到了282名参与者目标登记人数的三分之一以上。Alector还正在推进其针对广泛多样的蛋白质和酶靶标的临床前候选药物。

To align resources with these strategic priorities, Alector is reducing its workforce by approximately 17%.

为了使资源与这些战略优先事项保持一致，Alector正在减少约17%的员工。

As of September 30, 2024, Alector has $457.2 million in cash, cash equivalents, and investments, which the company continues to expect will provide a runway through 2026.

截至2024年9月30日，Alector拥有4.572亿美元的现金、现金等价物和投资，该公司预计这将为2026年提供一条跑道。

William Blair expressed surprise and disappointment at the update, given the strong scientific basis, evidence of target engagement, and potential signs of disease modification tied to ARIA cases. The analyst maintained the Outperform rating.

鉴于强有力的科学依据、目标参与的证据以及与ARIA病例相关的疾病改变的潜在迹象，威廉·布莱尔对这一更新表示惊讶和失望。该分析师维持了跑赢大市的评级。

Despite still seeing promise in TREM2 as a target and in neuroinflammatory modulation, the firm is removing AL002 from its model due to the study’s failure, underscoring the difficulties in developing treatments for neurodegenerative diseases.

尽管TREM2仍然有望成为靶标和神经炎症调节，但由于研究失败，该公司正在将AL002从其模型中删除，这突显了开发神经退行性疾病治疗方法的困难。

The analyst also expects AbbVie Inc ABBV to opt out of the program partnership and forgo the potential $250 million licensing payment.

该分析师还预计，AbbVie Inc ABBV将选择退出该计划的合作伙伴关系，并放弃潜在的2.5亿美元许可费。

AbbVie has an exclusive option to develop and commercialize AL002 globally.

AbbVie拥有全球AL002开发和商业化的独家选择权。

Price Action: ALEC stock is down 37.3% at $2.485 at last check Tuesday.

价格走势：周二最后一次检查时，亚历克股价下跌37.3%，至2.485美元。