Bristol Myers Squibb (NYSE: BMY) today announced topline results from the Phase 3 ARISE trial evaluating the efficacy and safety of Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia. In the Phase 3 trial, adjunctive Cobenfy treatment demonstrated a 2.0-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo with an atypical antipsychotic at Week 6, which did not reach the threshold for statistical significance for the primary endpoint (P = 0.11). Preliminary analyses suggest that Cobenfy as an adjunctive treatment to an atypical antipsychotic was associated with improvements in symptoms of schizophrenia compared to placebo plus an atypical antipsychotic for certain patients. In a post-hoc subgroup analysis there was a notable difference in response between subjects treated with risperidone as a background therapy compared with the remaining subjects treated with other background antipsychotics (non-risperidone). The initial analyses showed:

百时美施贵宝(Bristol Myers Squibb, NYSE: BMY)今天公布了 III 期 ARISE 试验的主要结果，该试验评估了Cobenfy（黄嘌呤诺美林和曲司氯铵）作为非典型抗精神病药物辅助治疗用于治疗精神分裂症症状控制不佳的成年患者的疗效和安全性。在 III 期试验中，与安慰剂加非典型抗精神病药物相比， Cobenfy辅助治疗在第 6 周显示阳性和阴性症状量表 (PANSS) 总分降低了 2.0 分，但未达到主要终点的统计学意义阈值 (P = 0.11)。初步分析表明，对于某些患者，与安慰剂加非典型抗精神病药物相比， Cobenfy作为非典型抗精神病药物的辅助治疗与精神分裂症症状的改善相关。在事后亚组分析中，以利培酮作为背景治疗的受试者与以其他背景抗精神病药物（非利培酮）治疗的受试者的反应存在显著差异。初步分析显示：

s safety and tolerability profile as an adjunctive treatment was consistent with previous monotherapy trials.

作为辅助治疗，其安全性和耐受性特征与之前的单药治疗试验一致。

Further analysis will follow, and the company will plan to speak with regulators about potential next steps.

将进一步进行分析，公司计划与监管机构讨论潜在的下一步行动。

'Adjunctive treatment trials in schizophrenia present significant clinical and methodological challenges,' said Husseini Manji, MD, FRCPC, Co-Chair, UK Government Mental Health Goals Program and Professor, Department of Psychiatry, Oxford University. 'When patients are already receiving treatment, demonstrating additional statistical benefit becomes inherently more difficult.

“精神分裂症的辅助治疗试验存在重大的临床和方法学挑战，”医学博士、英国政府心理健康目标计划联合主席、牛津大学精神病学系教授胡赛尼·曼吉说道。“当患者已经在接受治疗时，证明额外的统计学益处本身就变得更加困难。”

However, it’s common for individuals to continue to experience persistent symptoms, and prescribers have adopted an approach to address this significant unmet need through adjunctive use. Although .

然而，个体持续出现症状的情况很常见，开处方者已采用辅助使用的方法来应对这一显著的未满足需求。尽管如此。

did not demonstrate a statistically significant improvement as an adjunctive treatment in this trial, the data are encouraging, showing a noteworthy improvement for the majority of patients in the trial, as well as a tolerable safety profile. These findings warrant additional follow up and may provide valuable direction in our ongoing search for complementary approaches to address these persistent treatment gaps.'.

在这项试验中，作为辅助治疗并未显示出具有统计学意义的改善，但数据令人鼓舞，显示大多数患者在试验中有显著改善，并且安全性可接受。这些发现值得进一步跟进，可能为我们在持续寻找解决这些持久治疗缺口的补充方法上提供有价值的方向。

'Historically, the development of an effective, adjunctive treatment for schizophrenia has been difficult due to inherent challenges like variable patient response, stringent trial design requirements, and the complexities of demonstrating incremental benefits beyond established antipsychotics,' said .

“历史上，由于存在患者反应各异、试验设计要求严格以及证明超越现有抗精神病药物的增量效益复杂等固有挑战，开发一种有效的辅助治疗精神分裂症的方法一直很困难，”表示。

Samit Hirawat, MD

萨米特·希拉瓦特，医学博士

, executive vice president, chief medical officer and head of development at Bristol Myers Squibb. 'Despite the complex and challenging nature of adjunctive studies, we wanted to pursue research in this area to help more patients struggling with this condition. While the primary endpoint in this trial did not meet statistical significance, we need to complete our analysis and will plan to engage with the medical community and regulators to discuss these results and potential next steps.

布里斯托尔迈尔斯斯奎布公司的执行副总裁、首席医学官兼开发主管表示：“尽管辅助研究的性质复杂且具有挑战性，我们仍希望在这一领域开展研究，以帮助更多受此疾病困扰的患者。虽然该试验的主要终点未达到统计学显著性，但我们仍需完成分析，并计划与医学界和监管机构讨论这些结果及潜在的下一步措施。”

monotherapy has shown positive efficacy and safety in four pivotal studies, and provides a meaningful, differentiated treatment for people living with schizophrenia.”

“单药治疗在四项关键研究中显示出积极的有效性和安全性，为精神分裂症患者提供了有意义的、差异化的治疗方案。”

There is a robust clinical development program advancing for this important medicine

这个重要药物的临床开发项目正在积极推进。

across multiple neuropsychiatric conditions, including symptoms associated with Alzheimer's disease and autism spectrum disorder, bipolar disorder and other areas of significant clinical need.

跨越多种神经精神疾病，包括与阿尔茨海默病和自闭症谱系障碍、双相情感障碍及其他具有重要临床需求的领域相关的症状。

Bristol Myers Squibb will complete a full evaluation of the Phase 3 trial data and intends to present detailed results at an upcoming medical conference.

百时美施贵宝将完成对III期试验数据的全面评估，并计划在即将召开的医学会议上公布详细结果。

Bristol Myers Squibb thanks the patients, investigators and clinical trial sites who participated in the ARISE clinical trial.

百时美施贵宝感谢参与ARISE临床试验的患者、研究人员和临床试验机构。

About the Phase 3 ARISE Trial

关于三期ARISE试验

The ARISE clinical trial (KAR-012) is a Phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study evaluating

ARISE临床试验（KAR-012）是一项为期6周的III期、随机、双盲、安慰剂对照、多中心、门诊研究，评估

Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment in adults with schizophrenia who have inadequate response to their current antipsychotic treatment. The trial enrolled adults aged 18 to 65 years with schizophrenia who were on stable background therapy at the time of enrollment, with a Positive and Negative Syndrome Scale (PANSS) score of ≥70 at screening and randomization.

Cobenfy (xanomeline 和 trospium chloride) 作为成人精神分裂症患者的辅助治疗，这些患者对当前的抗精神病治疗反应不佳。试验招募了年龄在 18 至 65 岁之间、在入组时接受稳定背景治疗的精神分裂症患者，筛选和随机分组时阳性与阴性症状量表 (PANSS) 评分 ≥70。

The primary objective is to assess the efficacy of .

主要目的是评估 的功效。

Cobenfy as an adjunctive treatment to one of several atypical antipsychotics compared to placebo with an atypical antipsychotic as measured by change from baseline in PANSS total score at Week 6. The study also evaluated several secondary endpoints, including changes in Personal Social Performance (PSP), Clinical Global Impression-Severity (CGI-S), PANSS Marder Positive and Negative symptom factor scores, categorical response (defined as the proportion of subjects achieving ≥30% improvement in PANSS total score at Week 6), and Preference of Medication (POM)..

Cobenfy作为几种非典型抗精神病药物之一的辅助治疗，与安慰剂加非典型抗精神病药物相比，通过第6周PANSS总分从基线的变化来衡量。该研究还评估了几个次要终点，包括个人社会功能表现（PSP）、临床总体印象-严重度（CGI-S）、PANSS马德阳性与阴性症状因子评分、分类反应（定义为在第6周PANSS总分改善≥30%的受试者比例）以及药物偏好（POM）。

Following completion of the ARISE study, eligible participants may continue in a 52-week open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive

在ARISE研究完成后，符合条件的参与者可以继续参加为期52周的开放标签扩展（OLE）研究，以评估辅助治疗的长期安全性和耐受性。

About Schizophrenia

关于精神分裂症

Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels and behaves. There are three symptom domains of schizophrenia, which include positive symptoms (e.g., hallucinations, delusions, disordered thinking and speech), negative symptoms (e.g., lack of motivation, lack of emotional expression/flat affect, social withdrawal) and cognitive dysfunction (e.g., impaired attention, deficits in memory, concentration and decision-making).

精神分裂症是一种持续且常致残的精神疾病，影响一个人的思维、情感和行为方式。精神分裂症有三个症状领域，包括阳性症状（例如幻觉、妄想、思维和言语紊乱）、阴性症状（例如缺乏动力、缺乏情感表达/情感平淡、社交退缩）和认知功能障碍（例如注意力受损、记忆、专注力和决策能力缺陷）。

The symptoms of schizophrenia can affect all areas of people’s lives, making it difficult to maintain employment, live independently and manage relationships. Schizophrenia affects nearly 24 million people worldwide, including 2.8 million people in the United States, and is one of the top 15 leading causes of disability worldwide..

精神分裂症的症状会影响人们生活的各个方面，导致患者难以维持工作、独立生活和处理人际关系。精神分裂症影响着全球近2400万人，其中包括美国的280万人，并且是全球致残的前15大原因之一。

Bristol Myers Squibb: Transformational Research Advancing Neuroscience

百时美施贵宝：推动神经科学的变革性研究

Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. Neurological and neuropsychiatric conditions represent some of the greatest challenges of our time, bringing life-altering hardships to patients, caregivers and families throughout the course of these devastating diseases.

百时美施贵宝秉承着一个愿景——通过科学改变患者的生活。神经和神经精神疾病是我们这个时代面临的最大挑战之一，在这些毁灭性疾病的发展过程中，给患者、护理人员和家庭带来了改变生活的艰难困境。

Our researchers are committed to the pursuit of breakthrough science to develop life-changing medicines that modify disease and treat symptoms to improve quality of life. We have established a diverse neuroscience portfolio, including assets across a wide range of therapeutic modalities and mechanisms in conditions such as Alzheimer’s disease, schizophrenia, multiple sclerosis and more.

我们的研究人员致力于追求突破性的科学，开发改变生命的药物，这些药物能够改善疾病并治疗症状，从而提高生活质量。我们已经建立了一个多元化的神经科学产品组合，包括在阿尔茨海默病、精神分裂症、多发性硬化症等多种疾病中，涵盖广泛治疗模式和机制的资产。

With industry-leading capabilities, including our in-house neuroimaging program, we seek bold solutions to improve the treatment landscape. Evolution is in our DNA at Bristol Myers Squibb. We are motivated by the rapid progress of scientific knowledge within neuroscience and have an unwavering commitment to advance the most promising innovations to deliver transformational results for patients..

凭借行业领先的能力，包括我们内部的神经影像项目，我们寻求大胆的解决方案以改善治疗领域。在百时美施贵宝，进化深植于我们的DNA。我们受到神经科学领域科学知识快速进步的激励，并坚定不移地致力于推动最有前景的创新，为患者带来变革性的成果。

About Bristol Myers Squibb

关于百时美施贵宝

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram..

百时美施贵宝是一家全球生物制药公司，其使命是发现、开发和提供创新药物，帮助患者战胜严重疾病。如需了解更多关于百时美施贵宝的信息，请访问我们的网站BMS.com或在LinkedIn、X、YouTube、Facebook和Instagram上关注我们。