CAMBRIDGE, Mass., April 18, 2024 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today announced positive topline results from its pivotal Phase 3 TEMPO-3 trial for tavapadon, the first and only D1/D5 receptor partial agonist being studied as a once-daily treatment for Parkinson’s disease.

马萨诸塞州剑桥市，2024年4月18日（环球通讯社）--致力于解开大脑奥秘以治疗神经科学疾病的Cerevel Therapeutics（纳斯达克：CERE）公司今天宣布，其关键的3期TEMPO-3试验对tavapadon产生了积极的结果，tavapadon是第一个也是唯一一个D1/D5受体部分激动剂，被研究作为帕金森病的每日一次治疗方法。

The TEMPO-3 trial evaluated the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa (LD) in adults. The trial met its primary endpoint – patients treated with tavapadon adjunctive to LD experienced a clinically meaningful and statistically significant increase of 1.1 hours in total “on” time without troublesome dyskinesia compared to those treated with LD and placebo (1.7 hours vs.

TEMPO-3试验评估了他巴顿作为成人左旋多巴（LD）辅助治疗的有效性，安全性和耐受性。该试验达到了其主要终点-与接受LD和安慰剂治疗的患者相比，接受LD辅助治疗的患者总共“开启”时间增加了1.1小时，具有临床意义和统计学意义，而没有出现麻烦的运动障碍（1.7小时vs。

0.6 hours, p <0.0001). A statistically significant reduction in “off” time, the key secondary endpoint, was also observed for the tavapadon treatment arm..

0.6小时，p＜0.0001）。tavapadon治疗组的关键次要终点“关闭”时间也有统计学意义上的显着减少。。

“Tavapadon’s novel mechanism of action, which selectively activates the D1/D5 dopamine receptors, has demonstrated the potential to provide people living with Parkinson’s disease the right balance of motor control, safety and tolerability,” said Raymond Sanchez, M.D., chief medical officer, Cerevel Therapeutics.

Cerevel Therapeutics首席医疗官雷蒙德·桑切斯（RaymondSanchez）医学博士说：“塔瓦帕顿（Tavapadon）的新型作用机制选择性激活D1/D5多巴胺受体，已证明有潜力为帕金森病患者提供运动控制，安全性和耐受性的正确平衡。”。

“We are highly encouraged with the results announced today, and look forward to sharing additional data later this year from the monotherapy trials, TEMPO-1 and TEMPO-2, as we seek to evaluate tavapadon’s potential benefit to people living with Parkinson’s disease.”.

“我们对今天公布的结果感到非常鼓舞，并期待着在今年晚些时候分享单药治疗试验TEMPO-1和TEMPO-2的更多数据，因为我们试图评估塔瓦帕顿对帕金森病患者的潜在益处。”。

Tavapadon was generally well tolerated. The safety profile observed in the TEMPO-3 trial was consistent with prior clinical trials of tavapadon. The majority of adverse events reported were mild to moderate in severity.

塔瓦帕顿通常耐受性良好。在TEMPO-3试验中观察到的安全性与之前的塔瓦帕顿临床试验一致。报告的大多数不良事件的严重程度为轻度至中度。

“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,' said Hubert H.

“帕金森氏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，而不会产生与当前治疗相关的繁重副作用，”休伯特·H。

Fernandez, M.D., global principal investigator 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. “The results from the TEMPO-3 trial are particularly exciting as they demonstrate that tavapadon has the potential to offer an important new option for individuals living with this chronic, debilitating disease.”.

费尔南德斯（Fernandez，M.D.），全球首席研究员，詹姆斯·布朗（James and Constance Brown）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。“TEMPO-3试验的结果特别令人兴奋，因为他们证明塔瓦帕顿有可能为患有这种慢性衰弱性疾病的个体提供一个重要的新选择。”。

Full results from the TEMPO-3 study will be submitted for presentation at future medical meetings and used to support regulatory submissions of tavapadon as a treatment for Parkinson’s disease. Topline results from the Phase 3 monotherapy trials for tavapadon, TEMPO-1 and TEMPO-2, are expected in the second half of 2024..

TEMPO-3研究的完整结果将提交给未来的医学会议，并用于支持塔瓦巴顿作为帕金森病治疗药物的监管提交。tavapadon，TEMPO-1和TEMPO-2的3期单药治疗试验的结果预计将在2024年下半年公布。。

About TEMPO Clinical Development Program

关于TEMPO临床开发计划

The TEMPO clinical development program is evaluating the efficacy, safety and tolerability of tavapadon across a broad Parkinson’s population, including two monotherapy Phase 3 trials (TEMPO-1 and TEMPO-2) and one adjunctive Phase 3 trial (TEMPO-3). Cerevel is also conducting a fourth, open-label extension (OLE) trial (TEMPO-4) to assess the long-term safety and tolerability of tavapadon..

TEMPO临床开发计划正在评估塔瓦帕顿在广泛帕金森病人群中的疗效，安全性和耐受性，包括两项单药治疗3期试验（TEMPO-1和TEMPO-2）和一项辅助3期试验（TEMPO-3）。Cerevel还正在进行第四项开放标签扩展（OLE）试验（TEMPO-4），以评估塔瓦巴顿的长期安全性和耐受性。。

TEMPO-3 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, flexible-dose, 27-week trial to evaluate the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to LD for advanced Parkinson's disease. Patients were provided with a home diary to assess their motor function status (Hauser diary).

TEMPO-3是一项为期27周的3期双盲，随机，安慰剂对照，平行组，灵活剂量的试验，旨在评估他巴顿作为LD辅助治疗晚期帕金森病的疗效，安全性和耐受性。向患者提供家庭日记以评估其运动功能状态（Hauser日记）。

The primary endpoint was change from baseline in the total “on” time without troublesome dyskinesia based on the two-day average of the self-completed Hauser diary. Key secondary endpoints included change from baseline in total daily “off” time, change from baseline in total “on” and “off” time at earlier timepoints in the trial, and change from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II and III Scores..

根据自我完成的豪瑟日记的两天平均值，主要终点是总“开启”时间与基线的变化，而没有麻烦的运动障碍。关键的次要终点包括每日总“休息”时间与基线的变化，试验早期时间点总“开”和“关”时间与基线的变化，以及运动障碍协会-统一帕金森病评定量表（MDS-UPDRS）第一部分，第二部分和第三部分评分与基线的变化。。

A total of 507 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson’s disease, were experiencing motor fluctuations and were on a stable dose of LD for at least 4 weeks prior to screening. Patients were randomized to receive either tavapadon adjunctive to LD, titrated to 5-15 milligrams, or placebo and LD, orally and once-daily..

共有507名40-80岁的成年人参加了该试验。所有患者均确诊为帕金森氏病，正在经历运动波动，并且在筛查前至少服用稳定剂量的LD 4周。患者被随机分配接受口服和每日一次滴定至5-15毫克的LD辅助他瓦巴顿或安慰剂和LD。。

More information on the trial can be found on www.clinicaltrials.gov (NCT04542499).

有关该试验的更多信息，请访问www.clinicaltrials.gov（NCT04542499）。

About Tavapadon

关于塔瓦帕多

Tavapadon is the first and only selective D1/D5 receptor partial agonist in development for Parkinson’s disease and is currently being studied as a once-daily medicine for use as both a monotherapy and as an adjunctive therapy to LD. Tavapadon is designed to selectively and optimally activate D1/D5 receptors to potentially provide the right balance of motor control, safety and tolerability for patients.

Tavapadon是帕金森病开发中第一种也是唯一一种选择性D1/D5受体部分激动剂，目前正在研究作为每日一次的药物，既可作为单一疗法也可作为LD的辅助疗法。Tavapadon旨在选择性和最佳地激活D1/D5受体，以潜在地为患者提供运动控制，安全性和耐受性的正确平衡。

By selectively activating D1/D5 dopamine receptors along the nigrostriatal pathway, tavapadon has the potential to offer the right balance of dopamine signaling to improve motor control while avoiding D2/D3 overstimulation, which is believed to underlie many of the side effects of current dopamine agonists.

通过沿黑质纹状体途径选择性激活D1/D5多巴胺受体，塔瓦帕顿有可能提供多巴胺信号的正确平衡，以改善运动控制，同时避免D2/D3过度刺激，这被认为是目前多巴胺激动剂许多副作用的基础。

Additionally, as a partial agonist with a 24-hour half-life enabling once-daily dosing, tavapadon may avoid hyperactivation of the dopamine receptors, which can lead to troublesome dyskinesias.1,2.

此外，作为一种具有24小时半衰期的部分激动剂，可以每天给药一次，他巴顿可以避免多巴胺受体的过度活化，这可能导致麻烦的运动障碍[1,2]。

About Parkinson’s Disease

关于帕金森氏病

Parkinson’s disease is a chronic neurodegenerative disorder. It primarily results in progressive and debilitating motor symptoms, including decreased bodily movement, slowness of movement, rigidity, tremors and postural instability, all of which result from the loss of dopamine-producing neurons in the brain.3 A significant need exists for a new treatment option that has the right balance of dopamine signaling in order to provide sustained motor control without side effect tradeoffs across the disease spectrum.4,5 As of 2022, nearly 1 million individuals in the U.S.

帕金森氏病是一种慢性神经退行性疾病。它主要导致进行性和衰弱性运动症状，包括身体运动减少，运动缓慢，僵硬，震颤和姿势不稳定，所有这些都是由于大脑中产生多巴胺的神经元的丧失引起的。3迫切需要一种新的治疗选择，该治疗选择具有正确的多巴胺信号平衡，以提供持续的运动控制，而不会在整个疾病谱中产生副作用。4,5截至2022年，美国近100万人。

are estimated to be affected by Parkinson’s disease, which is expected to increase to over 1.6 million by 2037.6,7.

据估计，受帕金森氏病影响，预计到2037.6,7年，帕金森氏病将增加到160多万。

About Cerevel Therapeutics

关于Cerevel Therapeutics

Headquartered in Cambridge, Mass., Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company is tackling diseases by combining its deep expertise in neurocircuitry with a focus on targeted receptor subtype selectivity and a differentiated approach to pharmacology.

Cerevel Therapeutics总部位于马萨诸塞州剑桥市，致力于解开大脑的奥秘，治疗神经科学疾病。该公司正在通过将其在神经回路方面的深厚专业知识与靶向受体亚型选择性和差异化药理学方法相结合来应对疾病。

Cerevel Therapeutics has a diversified pipeline comprised of five clinical-stage investigational therapies and several preclinical compounds with the potential to treat a range of neuroscience diseases, including schizophrenia, Alzheimer’s disease psychosis, epilepsy, panic disorder and Parkinson’s disease..

Cerevel Therapeutics拥有一条多元化的渠道，包括五种临床阶段研究疗法和几种临床前化合物，这些化合物有可能治疗一系列神经科学疾病，包括精神分裂症、阿尔茨海默病、精神病、癫痫、恐慌症和帕金森病。。

On December 6, 2023, Cerevel announced that it had entered into an agreement to be acquired by AbbVie. Cerevel continues to expect the merger to close in the middle of 2024, subject to receipt of regulatory approvals and other customary closing conditions specified in the merger agreement.

2023年12月6日，Cerevel宣布已签订协议，由AbbVie收购。Cerevel继续预计合并将于2024年年中结束，但须获得监管部门的批准以及合并协议中规定的其他惯例性结束条件。