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Shares of Swiss drugmaker AC Immune rose by double-digits Thursday after the company reported positive data from a clinical trial testing its experimental vaccine for Parkinson’s disease.
瑞士制药公司AC Immune的股价在周四上涨了两位数,此前该公司报告了其帕金森病实验性疫苗临床试验的积极数据。
The vaccine is designed to spur the immune system to produce certain antibodies that can both break up and stop the spread of toxic clumps of “alpha-synuclein,” a protein
该疫苗旨在激发免疫系统产生某些抗体,这些抗体可以分解并阻止有毒的“α-突触核蛋白”聚集物的扩散。
closely linked to Parkinson’s
与帕金森病密切相关
. An ongoing, mid-stage trial has enrolled around 150 people at early stages of the disease, and is
一个正在进行的中期试验已经招募了大约150名处于疾病早期阶段的患者,并且正在
comparing three different doses
比较三种不同的剂量
of the immunotherapy against a placebo over a main study period of a year and a half.
在为期一年半的主要研究期间,免疫疗法与安慰剂的对比。
The first part of the experiment includes 34 participants who’ve been treated for somewhere between 12 and 18 months. According to AC Immune,
实验的第一部分包括34名已经接受治疗12到18个月的参与者。根据AC Immune公司的说法,
interim results show
初步结果显示
that not only is its therapy triggering the desired immune response, but biological markers as well as clinical measures of motor function suggest it may also be stabilizing patients’ disease. Movement issues like muscle shaking and difficulty balancing are hallmark symptoms of Parkinson’s.
不仅其治疗正在引发预期的免疫反应,而且生物标志物以及运动功能的临床指标表明它可能还在稳定患者的病情。肌肉颤抖和平衡困难等运动问题正是帕金森病的标志性症状。
The company noted, for example, how levels of a protein tied to nerve cell damage had increased in the placebo group but remained steady in the vaccine arms. For brain drug developers, demonstrating an effect on this “neurofilament light chain” protein has
例如,该公司指出,与神经细胞损伤相关的蛋白质水平在安慰剂组中有所增加,而在疫苗组中保持稳定。对于大脑药物开发者来说,证明对这种“神经丝轻链”蛋白产生影响具有重要意义。
become more important
变得越来越重要
over the past few years, ever since Biogen used that measurement
在过去的几年里,自从渤健使用了这项测量方法
to secure approval
获得批准
for an ALS medicine.
用于ALS药物。
AC Immune claims these results show, for the first time, that the progression of Parkinson’s could be slowed by using an active immunotherapy to target disease-causing alpha-synuclein.
AC Immune声称,这些结果首次表明,通过使用主动免疫疗法靶向致病的α-突触核蛋白,可以减缓帕金森病的进展。
'The remarkable consistency of the trends observed across multiple disease-related biomarkers and on clinical assessments in the treatment arm are very promising,” said Werner Poewe, an emeritus professor of neurology at Innsbruck Medical University in Austria, in a statement from AC Immune.
“在治疗组中,跨多个疾病相关生物标志物和临床评估所观察到的趋势具有显著一致性,这非常令人鼓舞,”奥地利因斯布鲁克医科大学神经学荣休教授沃纳·波伊韦在AC Immune的声明中表示。
“Overall, these findings are highly encouraging and fully support further development of the program,” Poewe added.
“总体而言,这些发现非常令人鼓舞,并且完全支持该计划的进一步发展,”Poewe补充道。
AC Immune said data collected at the trial’s 50-week and 76-week marks affirm that the immunotherapy is generally safe, well-tolerated, and that its benefits appear to outweigh the possible risks. Researchers have yet to report any “clinically relevant or serious adverse events” related to the shot.
AC Immune表示,在试验的第50周和第76周收集的数据证实,这种免疫疗法总体上是安全的,耐受性良好,其益处似乎超过了可能的风险。研究人员尚未报告任何与该疫苗相关的“具有临床意义或严重的不良事件”。
Transient injection site reactions were the most common adverse event, occurring in a little more than half of participants..
注射部位短暂反应是最常见的不良事件,发生在略多于一半的参与者中。
Fatigue and headaches were also documented in 12% and 15% of patients, respectively.
疲劳和头痛也分别在12%和15%的患者中有记录。
This immunotherapy has the potential to be a “tremendous step forward for millions of patients,” said AC Immune’s CEO Andrea Pfeifer. The safety and effectiveness seen so far create a “strong basis for accelerating development.”
AC Immune首席执行官安德里亚·普费弗表示,这种免疫疗法有潜力成为“数百万患者的巨大进步”。迄今为止所见的安全性和有效性为“加速开发提供了坚实的基础”。
Encouraged by these latest results, AC Immune intends to ask drug regulators for feedback on its development plans, to “potentially accelerate” the time to an approval filing. Final data from the first part of the Phase 2 trial are expected in the middle of next year.
受到这些最新结果的鼓舞,AC Immune 打算向药物监管机构征求对其开发计划的反馈,以“可能加速”批准申请的时间。第二阶段试验第一部分的最终数据预计将在明年年中公布。
Company shares, which trade on the Nasdaq, were up almost 14% by mid-day Thursday, to $3.17 apiece.
公司在纳斯达克上市的股票截至周四中午上涨了近14%,达到每股3.17美元。
With its stock price suppressed for much of the past three years, AC Immune recently conducted a strategic review that led the company to narrow its research lens and
由于其股价在过去三年的大部分时间里受到抑制,AC Immune 近期进行了一项战略评估,使公司缩小了研究范围并
lay off around 30% of its workforce
裁员约30%的员工
. AC Immune determined that, moving forward, it’ll prioritize three clinical-stage immunotherapy programs, plus some of its “most promising” small molecule drugs.
AC Immune 决定,未来将优先推进三个临床阶段的免疫治疗项目,以及一些“最有前景”的小分子药物。
The company has said these reductions should save enough money to keep it operational until at least the third quarter of 2027.
公司表示,这些削减措施应该可以节省足够的资金,使其至少在 2027 年第三季度之前保持运营。
The Parkinson’s vaccine is one of AC Immune’s few wholly-owned clinical programs.
帕金森疫苗是AC Immune少数几个完全拥有的临床项目之一。