BOSTON--(BUSINESS WIRE)--Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia..

BOSTON-（BUSINESS WIRE）-Karuna Therapeutics，Inc。（纳斯达克股票代码：KRTX），一家生物制药公司，致力于为患有精神和神经疾病的人发现，开发和提供转化药物，今天宣布向美国食品和药物管理局（FDA）提交用于治疗精神分裂症的KarXT（xanomeline trospium）的新药申请（NDA）。。

'Schizophrenia is a serious mental illness that affects how one thinks, feels, and behaves, with symptoms often appearing in patients in early adulthood, during the prime years of their lives,” said Bill Meury, president and chief executive officer of Karuna Therapeutics. “While current therapies have made a difference for many patients, they are not without limitations due to lack of full symptom relief or side effects that may lead to treatment discontinuation.

卡鲁纳治疗公司总裁兼首席执行官比尔·梅里（Bill Meury）说：“精神分裂症是一种严重的精神疾病，会影响人们的思考，感受和行为方式，症状通常出现在成年早期的患者生命的最初几年。“虽然目前的疗法对许多患者有所不同，但由于缺乏可能导致治疗中止的完全症状缓解或副作用，它们并非没有限制。

KarXT, if approved, will represent the first novel pharmacological approach to treating schizophrenia in several decades and provide a new treatment option for patients and their physicians.”.

如果获得批准，KarXT将代表几十年来治疗精神分裂症的第一种新型药理学方法，并为患者及其医生提供新的治疗选择。”。

“The NDA submission represents an important step toward helping patients in need. It is also a defining moment for Karuna Therapeutics. It represents the culmination of years of pre-clinical and clinical development, and a great deal of skill and hard work by our R&D organization. Our priorities over the next year are the regulatory review process, our ongoing development efforts, and building the platform to introduce KarXT to the medical community.

“NDA提交的文件是帮助有需要的患者迈出的重要一步，也是Karuna Therapeutics的决定性时刻，它代表了多年临床前和临床开发的高潮，以及我们研发组织的大量技能和辛勤工作。我们明年的优先事项是监管审查流程，我们正在进行的开发工作和建设向医学界介绍KarXT的平台。

I believe we are uniquely positioned to make a positive impact on how neuropsychiatric conditions are treated,” Meury added..

我相信我们处于独特的地位，可以对神经精神疾病的治疗方式产生积极影响，“Meury补充说。。

The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia. The EMERGENT program includes the three completed positive EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials evaluating the efficacy and safety of KarXT compared to placebo, and the ongoing EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety of KarXT.

NDA的提交得到了来自EMERGENT计划的有效性和长期安全性数据的支持，该计划是评估KarXT治疗精神分裂症的临床计划。紧急计划包括三项完成的积极紧急-1，紧急-2和紧急-3试验，评估KarXT与安慰剂相比的疗效和安全性，以及正在进行的紧急-4和紧急-5试验，评估长期KarXT的安全。

In all three placebo-controlled trials, KarXT met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo. KarXT also demonstrated reductions in both positive and negative symptoms of schizophrenia as measured by PANSS positive, PANSS negative, and PANSS negative Marder factor subscales, which were secondary endpoints in the trials..

在所有三项安慰剂对照试验中，KarXT均达到其主要终点，与安慰剂相比，阳性和阴性症状量表（PANSS）总分显示统计学显着和临床意义上的降低。通过PANSS阳性，PANSS阴性和PANSS阴性Marder因子分量表测量，KarXT还显示精神分裂症的阳性和阴性症状均减少，这是试验的次要终点。。

KarXT was found to be generally well-tolerated, with the most common adverse events being cholinergic in nature and rated mild to moderate in severity. Discontinuation rates due to treatment emergent adverse events were low and similar between KarXT and placebo across all trials. Notably, KarXT was not associated with common side effects of currently available antipsychotics, including changes in metabolic function, weight gain, somnolence, and extrapyramidal symptoms..

发现KarXT通常具有良好的耐受性，最常见的不良事件本质上是胆碱能，严重程度评定为轻度至中度。在所有试验中，KarXT和安慰剂之间由于治疗紧急不良事件导致的停药率较低且相似。值得注意的是，KarXT与目前可用的抗精神病药物的常见副作用无关，包括代谢功能，体重增加，嗜睡和锥体外系症状的改变。。

About KarXT

关于KarXT

KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis related to Alzheimer’s disease. Through its novel mechanism of action, KarXT acts as a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, which is thought to mediate positive, negative, and cognitive symptoms of schizophrenia.

KarXT（xanomeline trospium）是一种研究性毒蕈碱类抗精神病药物，用于治疗与阿尔茨海默病相关的精神分裂症和精神病。通过其新的作用机制，KarXT在中枢神经系统中充当双重M1/M4毒蕈碱乙酰胆碱受体激动剂，其被认为介导精神分裂症的阳性，阴性和认知症状。

Unlike existing treatments, KarXT does not directly block dopamine receptors, representing a potential new approach to treating schizophrenia..

与现有治疗方法不同，KarXT不直接阻断多巴胺受体，代表了治疗精神分裂症的潜在新方法。。

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, and affects nearly 24 million people worldwide, including 2.8 million people in the U.S. It is characterized by three symptom domains: positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawal from others), and cognitive impairment (deficits in memory, concentration, and decision-making).

精神分裂症是一种持续且经常致残的精神疾病，会影响一个人的思考，感受和行为方式，并影响全球近2400万人，其中包括美国的280万人。它的特征是三个症状领域：阳性症状（幻觉和妄想），阴性症状（享受生活和退学困难），和认知障碍（记忆力，注意力和决策能力不足）。

In part due to limitations with current treatments, people living with schizophrenia often struggle to maintain employment, live independently, and manage relationships. While current treatments can be effective in managing select symptoms, approximately 30% of people to do not respond to therapy, with an additional 50% experiencing only a partial improvement in symptoms or unacceptable side effects..

部分由于目前治疗的局限性，精神分裂症患者往往难以维持就业，独立生活和管理人际关系。虽然目前的治疗方法可以有效地控制某些症状，但大约30%的人对治疗没有反应，另外50%的人仅出现部分症状改善或不可接受的副作用。。

About Karuna

关于卡鲁纳

Karuna Therapeutics is a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by serious mental illness.

Karuna Therapeutics是一家生物制药公司，致力于为患有精神病和神经疾病的人发现，开发和提供变革性药物。在卡鲁纳，我们了解需要有区别和更有效的治疗方法来帮助患者应对严重精神疾病带来的挑战。

Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives. For more information, please visit www.karunatx.com..

利用我们广泛的神经科学知识，我们正在利用大脑尚未开发的潜力，寻求新的途径来开发能够在人们生活中产生有意义差异的药物。欲了解更多信息，请访问www.karunatx.com。。

Forward Looking Statements

前瞻性声明

This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our goals to develop and commercialize our product candidates, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms.

本新闻稿包含1933年“证券法”（经修订）第27A条和1934年“证券交易所法”（经修订）第21E条含义内的前瞻性声明，包括有关我们开发和商业化候选产品目标的声明，以及其他用“可以”，“期望”，“意图”，“可以”，“计划”，“潜力”，“应该”，“将会”或类似表达方式和这些术语的否定词标识的陈述。

Forward looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to obtain necessary funding, our ability to generate positive clinical trial results for our product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, risks relating to business interruptions, and other risks set forth under the heading “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2022 and in our subsequent filings with the Securities and Exchange Commission.

前瞻性声明不是对未来业绩的承诺或保证，并且受到各种风险和不确定性的影响，其中许多风险和不确定性是我们无法控制的，并且可能导致实际结果与此类前瞻性声明中预期的结果大不相同。这些因素包括与我们有限的运营历史相关的风险，我们获得必要资金的能力，我们为产品候选人产生积极临床试验结果的能力以及临床开发中固有的其他风险，监管审批的时间和范围，法律和我们所处法规的变化，竞争压力，我们能够确定额外的候选产品，与业务中断有关的风险以及我们在2022年12月31日结束的年度10-K表格年度报告“风险因素”标题下提出的其他风险，以及我们随后提交的文件证券交易所。

Our actual results could differ materially from the results described in or implied by such forward looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements..

我们的实际结果可能与此类前瞻性声明中描述或暗示的结果大不相同。前瞻性声明仅在本声明签署之日起生效，除法律规定外，我们不承担更新或修改这些前瞻性声明的义务。。