26, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from its pivotal Phase 3 TEMPO-1 trial for tavapadon as a monotherapy in early Parkinson's disease. Tavapadon is an investigational D1/D5 dopamine receptor partial agonist being studied as a once-daily treatment for Parkinson's disease..

2024年2月26日/新闻通讯社/--AbbVie（纽约证券交易所：ABBV）今天宣布，其关键的3期TEMPO-1试验结果显示，塔瓦巴顿作为早期帕金森病的单一疗法取得了积极的结果。Tavapadon是一种研究性D1/D5多巴胺受体部分激动剂，正在研究作为帕金森病的每日一次治疗方法。。

The TEMPO-1 trial evaluated the efficacy, safety and tolerability of two fixed doses (5 mg and 15 mg, once daily) of tavapadon as a monotherapy in adults with early Parkinson's disease. The trial met its primary endpoint – patients treated with tavapadon in both dose groups experienced a statistically significant reduction (improvement) from baseline compared to placebo (placebo: +1.8; 5 mg: -9.7; 15 mg: -10.2; p-value <0.0001 each dose versus placebo) in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26..

TEMPO-1试验评估了两种固定剂量（5 mg和15 mg，每日一次）的他巴顿作为早期帕金森病成人单药治疗的疗效，安全性和耐受性。该试验达到了其主要终点-在运动障碍学会-统一帕金森病评定量表（MDS-UPDRS）第26周的第二部分和第三部分综合评分中，与安慰剂相比，两个剂量组接受tavapadon治疗的患者在基线水平上均有统计学显着降低（改善）（安慰剂：+1.8；5 mg:-9.7；15 mg:-10.2；p值<0.0001，每个剂量与安慰剂相比）。。

The TEMPO-1 trial also met the key secondary endpoint, demonstrating a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living (MDS-UPDRS Part II) in both tavapadon dose groups compared to placebo at week 26.

TEMPO-1试验也达到了关键的次要终点，表明在第26周，与安慰剂相比，两个tavapadon剂量组的日常生活体验（MDS-UPDRS第二部分）的运动方面均有统计学意义和临床意义的改善。

'The TEMPO-1 data, coupled with the previously reported TEMPO-3 adjunctive trial findings, further support the potential of tavapadon for people living with Parkinson's disease,' said Primal Kaur, MD, MBA, senior vice president, immunology, neuroscience, eye care and specialty development, AbbVie. 'This marks a significant step forward in our commitment to enhancing our neuroscience portfolio following the strategic acquisition of Cerevel Therapeutics and further demonstrates our dedication to supporting patients at all stages of this challenging neurological condition.

AbbVie免疫学、神经科学、眼科护理和专业发展高级副总裁、医学博士、MBA Primal Kaur说，“TEMPO-1数据，加上先前报道的TEMPO-3辅助试验结果，进一步支持了他巴顿对帕金森病患者的潜力。”这标志着在战略收购Cerevel Therapeutics后，我们致力于增强我们的神经科学投资组合，迈出了重要的一步，并进一步证明了我们致力于支持处于这一具有挑战性的神经系统疾病各个阶段的患者。

We look forward to sharing additional data later this year from the TEMPO-2 monotherapy trial.'.

我们期待着在今年晚些时候分享TEMPO-2单一疗法试验的更多数据。”。

The safety profile observed in the TEMPO-1 trial was consistent with prior clinical trials.1,2 The majority of adverse events reported were mild to moderate in severity.

TEMPO-1试验中观察到的安全性与之前的临床试验一致[1,2]。报告的大多数不良事件的严重程度为轻度至中度。

Full results from the TEMPO-1 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 TEMPO-2, the Phase 3 flexible-dose monotherapy trial for tavapadon, are expected by the end of 2024..

TEMPO-1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。预计到2024年底，TEMPO-2（tavapadon的第三阶段灵活剂量单药治疗试验）的最终结果。。

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.

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所致。

About Tavapadon

关于塔瓦帕多

Tavapadon is a 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 levodopa. The safety and efficacy of investigational tavapadon has not been established..

Tavapadon是帕金森病开发中的选择性D1/D5受体部分激动剂，目前正在作为每日一次的药物进行研究，用作单一疗法和左旋多巴的辅助疗法。研究性塔瓦巴顿的安全性和有效性尚未确定。。

TEMPO Clinical Development Program

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 disease population, including two monotherapy Phase 3 trials (TEMPO-1 and TEMPO-2) and one adjunctive Phase 3 trial (TEMPO-3). AbbVie 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的帕金森病人群中的疗效，安全性和耐受性，包括两项单一疗法3期试验（TEMPO-1和TEMPO-2）和一项辅助3期试验（TEMPO-3）。AbbVie还进行了第四次开放标签扩展（OLE）试验（TEMPO-4），以评估塔瓦巴顿的长期安全性和耐受性。。

TEMPO-1 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, 27-week trial to evaluate the efficacy, safety and tolerability of two fixed doses of tavapadon as a monotherapy in early Parkinson's disease. The primary endpoint was the change from baseline in the MDS-UPDRS Parts II and III combined score.

TEMPO-1是一项为期27周的3期双盲，随机，安慰剂对照，平行组试验，旨在评估两种固定剂量的他巴顿作为早期帕金森病单一疗法的疗效，安全性和耐受性。主要终点是MDS-UPDRS第二部分和第三部分综合评分与基线的变化。

Key secondary endpoints included change from baseline in the MDS-UPDRS Parts II score and percentage of responders with 'much improved' or 'very much improved' on the Patient Global Impression of Change (PGIC)..

关键的次要终点包括MDS-UPDRS第二部分评分与基线相比的变化，以及患者总体变化印象（PGIC）“大大改善”或“非常改善”的应答者百分比。。

The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. It includes a motor evaluation and characterizes the extent and burden of disease across various populations.4 Part II contains 13 sub-scores for the motor experiences of daily living and Part III contains 33 sub-scores based on 18 items, several with right, left or other body distribution scores for the motor examination.

MDS-UPDRS旨在评估帕金森病的各个方面，包括日常生活的非运动和运动经历以及运动并发症。它包括运动评估，并描述了不同人群的疾病程度和负担。第二部分包含日常生活运动经历的13个子分数，第三部分包含基于18个项目的33个子分数，其中几个具有右，左或其他身体分布分数用于运动检查。

The sub-score for each is summed to calculate the total scores. The scale range for Part II+III Total Score is 0-184 (Part II maximum total score of 52 + Part III maximum total score of 132). The higher the score the greater the severity. A negative change from baseline represents an improvement in motor function.5.

将每个子分数相加以计算总分。第二部分+第三部分总分的量表范围为0-184（第二部分最高总分52分+第三部分最高总分132分）。分数越高，严重程度越高。与基线相比的负面变化代表运动功能的改善。

A total of 529 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson's disease and had disease duration (from time of diagnosis) of less than three years. Patients were randomized to receive tavapadon titrated to 5 milligrams, tavapadon titrated to 15 milligrams or placebo, orally and once-daily..

共有529名年龄在40-80岁之间的成年人参加了该试验。所有患者均确诊为帕金森氏病，病程（从诊断时起）不到三年。患者被随机分配接受滴定至5毫克的塔瓦帕顿，滴定至15毫克的塔瓦帕顿或安慰剂，口服和每日一次。。

About AbbVie in Neuroscience

关于神经科学中的AbbVie

At AbbVie, our commitment to preserving personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's Neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders and psychiatric disorders, along with a robust pipeline of transformative therapies.

在艾伯维，我们坚定不移地致力于保护世界各地患有神经和精神疾病的人的人格。凭借30多年的神经科学经验，我们今天正在提供有意义的治疗选择，并推动未来的创新。AbbVie的神经科学投资组合包括批准的神经疾病治疗，包括偏头痛，运动障碍和精神疾病，以及强大的转化疗法。

We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners and clinicians.

我们在研究方面进行了大量投资，并致力于加深对神经和精神疾病的了解。每一个挑战都使我们更有决心，并促使我们为那些受这些疾病影响的人、他们的护理合作伙伴和临床医生发现并提供进步。

About AbbVie

关于AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

我们致力于在几个关键治疗领域（免疫学、肿瘤学、神经科学和眼部护理）以及Allergan美学产品组合中的产品和服务，对人们的生活产生重大影响。