An experimental Parkinson’s disease drug on its way to AbbVie as part of an $8.7 billion acquisition has met the goals of a pivotal study, setting up the pharmaceutical giant with a drug prospect that could be ready for regulatory submissions after the expected deal close later this year.

作为87亿美元收购的一部分，一种实验性帕金森氏病药物正在前往AbbVie的途中，已经达到了一项关键研究的目标，为这家制药巨头建立了一个药物前景，在预期的交易于今年晚些时候结束后，该药物有望提交监管部门。

According to the preliminary results reported Thursday by the drug’s developer, Cambridge, Massachusetts-based Cerevel Therapeutics, treatment with tavapadon led to a longer time during which Parkinson’s motor symptoms were controlled. Patients who received the Cerevel drug experienced a statistically significant increase in this total “on” time, the company said..

根据该药物开发人员、位于马萨诸塞州剑桥的Cerevel Therapeutics周四报告的初步结果，使用塔瓦巴顿治疗可以延长帕金森氏症运动症状得到控制的时间。该公司表示，接受Cerevel药物治疗的患者的总“开启”时间在统计学上显着增加。。

In Parkinson’s, patients lack sufficient levels of dopamine, a neurotransmitter that plays a role in regulating muscle movement. Standard treatment is levodopa, a drug that converts to dopamine in the body. Other available treatments include dopamine agonists, drugs that activate dopamine receptors in the brain.

帕金森氏症患者缺乏足够水平的多巴胺，多巴胺是一种调节肌肉运动的神经递质。标准治疗方法是左旋多巴，一种在体内转化为多巴胺的药物。其他可用的治疗方法包括多巴胺激动剂，即激活大脑中多巴胺受体的药物。

Cerevel’s tavapadon is a small molecule designed to selectively target the D1 and D5 receptors, avoiding other dopamine receptors that can trigger side effects. Furthermore, the once-daily oral drug is a partial agonist, which the company contends activates its target receptors in a way that achieves a balance of motor control, safety, and tolerability.

Cerevel的tavapadon是一种小分子，旨在选择性靶向D1和D5受体，避免其他可能引发副作用的多巴胺受体。此外，每日一次的口服药物是一种部分激动剂，该公司认为它可以激活其靶受体，从而实现运动控制，安全性和耐受性的平衡。

Cerevel claims tavapadon is the first and only selective D1/D5 partial agonist in development for Parkinson’s..

Cerevel声称，塔瓦帕顿是帕金森氏症发展中第一个也是唯一一个选择性D1/D5部分激动剂。。

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The Phase 3 study enrolled 507 adults with a confirmed Parkinson’s diagnosis. These study participants experienced motor fluctuations and were receiving levodopa for at least four weeks prior to screening. Patients in the 27-week trial were randomly assigned to receive either the Cerevel drug and levodopa or a placebo and levodopa.

这项3期研究招募了507名确诊帕金森氏症的成年人。这些研究参与者经历了运动波动，并在筛查前接受左旋多巴至少四周。27周试验中的患者被随机分配接受Cerevel药物和左旋多巴或安慰剂和左旋多巴。

The main goal was to measure the change from baseline in the total “on” time without involuntary troublesome dyskinesia, or involuntary muscle movements. Secondary goals included measuring the “off” time when motor symptoms reappear..

主要目标是测量总“开启”时间与基线的变化，而不会出现非自愿的麻烦性运动障碍或非自愿的肌肉运动。次要目标包括测量运动症状再次出现时的“关闭”时间。。

Cerevel reported that the study drug arm showed a 1.7 hour increase in “on” time versus a 0.6 hour increase in the placebo group, results that were both statistically significant and clinically meaningful. On the key secondary goal measuring “off” time, the company said the reduction in the tavapadon arm was also statistically significant.

Cerevel报告说，研究药物组的“开启”时间增加了1.7小时，而安慰剂组增加了0.6小时，结果具有统计学意义和临床意义。关于衡量“休息”时间的关键次要目标，该公司表示，塔瓦帕顿手臂的减少也具有统计学意义。

Cerevel said tavapadon was generally well tolerated by patients in the study, adding that the drug’s safety profile was consistent with prior clinical trials. The majority of adverse events reported were characterized as mild to moderate in severity..

Cerevel说，研究中的患者对塔瓦巴顿的耐受性总体良好，并补充说该药物的安全性与之前的临床试验一致。报告的大多数不良事件的严重程度为轻度至中度。。

Full Phase 3 results will be submitted for presentation at future medical meetings, Cerevel said. The results will also support regulatory submissions of the drug. Two additional Phase 3 clinical trials are ongoing evaluating tavapadon as a monotherapy. Cerevel expects to report preliminary data from these studies in the second half of this year.

Cerevel说，完整的第三阶段结果将提交给未来的医学会议。结果也将支持该药物的监管提交。另外两项3期临床试验正在评估他巴顿作为单一疗法。Cerevel预计将在今年下半年报告这些研究的初步数据。

Hubert Fernandez, global principal investigator in the tavapadon studies and the James and Constance Brown endowed chair in movement disorders, professor of neurology, and director at the Center for Neurological Restoration at Cleveland Clinic, said the trial results demonstrate that the Cerevel drug has the potential to offer a new treatment option for Parkinson’s patients..

塔瓦帕顿研究的全球首席研究员、詹姆斯和康斯坦斯·布朗运动障碍基金会主席、神经病学教授、克利夫兰诊所神经修复中心主任休伯特·费尔南德斯表示，试验结果表明，Cerevel药物有可能为帕金森病患者提供新的治疗选择。。

“Parkinson’s disease is the fastest growing neurodegenerative disorder in the world, and a significant need exists for a new treatment option that provides the right balance of dopamine signaling and delivers sustained motor control without the burdensome side effects associated with current treatments,” Fernandez said in a prepared statement..

费尔南德斯在一份准备好的声明中说：“帕金森病是世界上发展最快的神经退行性疾病，迫切需要一种新的治疗选择，这种治疗选择可以提供多巴胺信号的正确平衡，并提供持续的运动控制，而不产生与当前治疗相关的繁重副作用。”。。

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特种药物是一类用于治疗复杂、慢性或罕见疾病的处方药。虽然这种分类最初是为了定义罕见的，也称为“孤儿”疾病的治疗方法，在美国影响不到20万人，但最近，特种药物已成为治疗慢性和复杂疾病的基石，如癌症，自身免疫性疾病，糖尿病，丙型肝炎和艾滋病毒/艾滋病。

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Cerevel focuses on developing drugs for neuroscience indications. The biotech’s pipeline includes emraclidine, a schizophrenia drug candidate in mid-stage clinical testing that could compete with drugs from Bristol Myers Squibb and Neurocrine Sciences. Cerevel has additional clinical-stage programs addressing epilepsy, panic disorder, and dementia-related apathy..

Cerevel专注于开发用于神经科学适应症的药物。该生物技术公司的产品线包括emraclidine，一种中期临床试验中的精神分裂症候选药物，可能与百时美施贵宝和神经分泌科学公司的药物竞争。Cerevel还有其他针对癫痫，恐慌症和痴呆相关冷漠的临床阶段计划。。

Last December, AbbVie announced an agreement to buy Cerevel, which it said complemented its own neuroscience portfolio. AbbVie markets drugs for migraine, movement disorders, and psychiatric disorders. In Parkinson’s, AbbVie sells Duopa (Duodopa outside the U.S.), a combination of levodopa and carbidopa for treating advanced stages of the disease.

去年12月，AbbVie宣布了收购Cerevel的协议，该协议补充了其自己的神经科学投资组合。AbbVie销售治疗偏头痛、运动障碍和精神障碍的药物。在帕金森氏症中，AbbVie销售Duopa（美国以外的Duodopa），它是左旋多巴和卡比多巴的组合，用于治疗疾病的晚期。

The company had also developed ABBV-951 for treating motor fluctuations in adults with advanced Parkinson’s. Last year, the FDA turned down AbbVie’s new drug application for ABBV-951 and asked for more information about the pump that administers the drug. AbbVie said the regulator did not ask for any additional clinical testing..

该公司还开发了ABBV-951，用于治疗晚期帕金森氏症患者的运动波动。去年，FDA拒绝了AbbVie针对ABBV-951的新药申请，并要求提供有关该药物管理泵的更多信息。AbbVie表示，监管机构没有要求进行任何额外的临床测试。。

Cerevel said it continues to expect the acquisition to close in the middle of this year, subject to receipt of regulatory approvals and other customary closing conditions.

Cerevel表示，预计此次收购将在今年年中结束，但须获得监管部门的批准和其他常规的结束条件。

Image: Dr_Microbe, Getty Images

图片：微生物博士，盖蒂图片

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