9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating investigational tavapadon as a flexible-dose monotherapy in early Parkinson's disease. Tavapadon is the first and only D1/D5 partial agonist under investigation as a once-daily treatment for Parkinson's disease..

92024/PRNewswire/--AbbVie（纽约证券交易所：ABBV）今天宣布，其关键的3期TEMPO-2试验评估了研究性塔瓦巴顿作为早期帕金森病的灵活剂量单一疗法的积极结果。Tavapadon是第一个也是唯一一个正在研究的D1/D5部分激动剂，作为帕金森病的每日一次治疗药物。。

The TEMPO-2 trial evaluated the efficacy, safety and tolerability of a flexible-dose (5 mg to 15 mg, once daily) treatment with tavapadon as a monotherapy in adults with early Parkinson's disease. The trial met its primary endpoint – patients treated with tavapadon experienced a statistically significant reduction (improvement) from baseline compared to placebo (placebo: -1.2; tavapadon 5-15 mg: -10.3; p-value <0.0001 versus placebo) in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.1.

TEMPO-2试验评估了灵活剂量（5 mg至15 mg，每日一次）治疗早期帕金森病成人的有效性，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-帕金森病统一评定量表（MDS-UPDRS）第26.1周的第二部分和第三部分综合评分中，与安慰剂相比，接受塔瓦帕顿治疗的患者比基线有统计学显着降低（改善）（安慰剂：-1.2；塔瓦帕顿5-15 mg：-10.3；与安慰剂相比，p值<0.0001）。

The TEMPO-2 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 the tavapadon group (5-15 mg) compared to placebo at week 26.1

TEMPO-2试验也达到了关键的次要终点，表明塔瓦帕顿组（5-15 mg）与安慰剂相比，在第26.1周的日常生活体验（MDS-UPDRS第二部分）的运动方面有统计学意义和临床意义的改善

'The positive results across all three Phase 3 TEMPO trials underscore the potential of tavapadon as a first-in-class D1/D5 partial agonist for the treatment of Parkinson's disease,' said Primal Kaur, M.D., MBA, senior vice president, immunology, neuroscience, eye care and specialty development, AbbVie.

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：“所有三项TEMPO 3期临床试验的积极结果都突显了他巴顿作为治疗帕金森病的一流D1/D5部分激动剂的潜力。”。

'With these data in hand, we look forward to working with regulatory agencies to assess next steps, bringing us one step closer to providing tavapadon for those living with this chronic, debilitating disease.'.

“有了这些数据，我们期待着与监管机构合作评估下一步，使我们更接近为患有这种慢性衰弱性疾病的人提供塔瓦巴顿。”。

The safety profile observed in the TEMPO-2 trial was consistent with prior clinical trials.1,2,6 The majority of adverse events reported were mild to moderate in severity.1

在TEMPO-2试验中观察到的安全性与之前的临床试验一致[1,2,6]。报告的大多数不良事件的严重程度为轻度至中度

'Parkinson's disease imposes a profound burden on individuals living with this challenging neurological condition, significantly affecting their quality of life and management of daily activities. Right now, there is still an unmet need for treatments that deliver efficacy while minimizing unwanted side effects,' said Hubert H.

帕金森氏病给患有这种具有挑战性的神经系统疾病的个体带来了沉重的负担，严重影响了他们的生活质量和日常活动管理。休伯特·H.说，目前，对于既能产生疗效，又能最大限度地减少不必要的副作用的治疗方法的需求仍未得到满足。

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 TEMPO-2, and across the entire TEMPO clinical development program, add to the growing evidence which suggests that tavapadon has the potential to offer an important new option for individuals living with Parkinson's 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-2和整个TEMPO临床开发计划的结果增加了越来越多的证据，表明塔瓦帕顿有可能为帕金森病患者提供重要的新选择。”。

Full results from the TEMPO-2 trial will be submitted for presentation at a future medical meeting. AbbVie is on track to submit the New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in 2025.

TEMPO-2试验的全部结果将提交给未来的医学会议。AbbVie有望在2025年向美国食品和药物管理局（FDA）提交新药申请（NDA）。

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Tavapadon

Tavapadon is the first and only selective D1/D5 receptor partial agonist under investigation 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是帕金森病研究中第一个也是唯一一个选择性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 evaluated 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临床开发计划评估了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，包括两项单药治疗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-2 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, 27-week trial to evaluate the efficacy, safety and tolerability of flexible doses of tavapadon (5-15 mg QD) 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-2是一项为期27周的3期双盲，随机，安慰剂对照，平行组试验，旨在评估灵活剂量的他伐帕顿（5-15 mg QD）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 304 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 5-15 mg QD or placebo, orally and once daily.

共有304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，病程（从诊断时起）不到三年。患者被随机分为口服和每日一次，每天一次，每天一次，每天一次，每天一次，每次5-15毫克。

AbbVie plans to submit an NDA for tavapadon leveraging data from the TEMPO program to the FDA in 2025.

AbbVie计划在2025年利用TEMPO计划的数据向FDA提交塔瓦巴顿的NDA。

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，并促使我们发现并为受这些疾病影响的人、他们的护理合作伙伴和临床医生提供进步。

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.

AbbVie的使命是发现并提供创新药物和解决方案，以解决当今严重的健康问题，并应对未来的医疗挑战。我们致力于在免疫学、肿瘤学、神经科学和眼部护理等几个关键治疗领域，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。