Alto Neuroscience, Inc. a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALTO-101 for the treatment of cognitive impairment associated with schizophrenia (CIAS).

Alto Neuroscience, Inc.是一家专注于开发神经精神疾病新型精准药物的临床阶段生物制药公司，今天宣布美国食品和药物管理局（FDA）已授予ALTO-101快速通道资格，用于治疗与精神分裂症相关的认知障碍（CIAS）。

There are currently no approved treatments for CIAS, a core feature of schizophrenia that severely impacts daily functioning and quality of life for millions of patients..

目前，尚无获批的CIAS治疗方法，而CIAS是精神分裂症的核心特征，严重影响着数百万患者的日常生活和生活质量。

Fast Track designation is an FDA process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation may be eligible for more frequent meetings with the FDA to discuss the drug’s development plan, as well as eligibility for accelerated approval and priority review, if relevant criteria are met..

快速通道资格是 FDA 设计的一种流程，旨在促进用于治疗严重疾病并满足未满足医疗需求的药物的开发，并加快其审评速度。获得快速通道资格的药物可能有资格与 FDA 更频繁地召开会议，讨论药物的开发计划，并在符合相关标准的情况下，获得加速批准和优先审评资格。

“Receiving Fast Track designation from the FDA underscores the critical need for new, effective treatments for patients suffering from cognitive impairment associated with schizophrenia,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “This designation is a significant milestone for the ALTO-101 program and we believe it is a testament to its potential as a novel treatment approach.

“从FDA获得快速通道资格突显了对于治疗精神分裂症相关认知障碍的患者，迫切需要新的有效治疗方法，”Alto Neuroscience创始人兼首席执行官Amit Etkin博士表示，“这一资格是ALTO-101项目的重要里程碑，我们认为它证明了其作为一种创新治疗手段的潜力。”

Our Phase 1 data, which demonstrated significant and clinically relevant effects of ALTO-101 on both EEG measures and cognitive performance in healthy subjects, provides strong validation for its mechanism. We are committed to advancing this program expeditiously for the millions of patients who currently have no approved treatment options to address these debilitating cognitive deficits.”.

我们的第一阶段数据表明，ALTO-101对健康受试者的脑电图测量和认知表现均有显著且临床相关的影响，这为其作用机制提供了有力验证。我们致力于快速推进这一项目，为数百万目前尚无获批治疗选择的患者解决这些令人衰弱的认知缺陷。”

ALTO-101 is a novel small molecule phosphodiesterase-4 (PDE4) inhibitor. The PDE4 enzyme plays a key role in the brain by breaking down cyclic adenosine monophosphate (cAMP), a molecule crucial for neuronal signaling and synaptic plasticity, which are fundamental to learning and memory. By inhibiting PDE4, ALTO-101 increases cAMP levels, which is believed to enhance neural circuits and improve cognitive function.

ALTO-101 是一种新型的小分子磷酸二酯酶-4（PDE4）抑制剂。PDE4 酶在大脑中通过分解环磷酸腺苷（cAMP）发挥关键作用，cAMP 是神经信号传递和突触可塑性至关重要的分子，而这些对于学习和记忆至关重要。通过抑制 PDE4，ALTO-101 提高了 cAMP 的水平，这被认为可以增强神经回路并改善认知功能。

The cognitive deficits in schizophrenia, which include impaired attention, memory, and executive function, represent a substantial and underserved aspect of the illness..

精神分裂症的认知缺陷，包括注意力、记忆力和执行功能受损，代表了该疾病一个重大且未被充分关注的方面。

About Cognitive Impairment Associated with Schizophrenia (CIAS)

关于与精神分裂症相关的认知障碍（CIAS）

Cognitive impairment is a core and disabling feature of schizophrenia, affecting areas such as memory, attention, processing speed, and executive function. These deficits are a primary determinant of poor functional outcomes for patients, impacting their ability to work, maintain social relationships, and live independently.

认知障碍是精神分裂症的核心且致残的特征，影响记忆、注意力、处理速度和执行功能等领域。这些缺陷是患者功能结果不佳的主要决定因素，影响他们工作、维持社交关系和独立生活的能力。

Currently, there are no approved treatments for CIAS, representing a significant unmet medical need for the millions of people living with schizophrenia worldwide..

目前，尚无获批的CIAS治疗方法，这代表了全球数百万精神分裂症患者的重大未满足医疗需求。

About Alto Neuroscience

关于Alto Neuroscience

Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates.

Alto Neuroscience是一家临床阶段的生物制药公司，致力于通过利用神经生物学重新定义精神病学，开发个性化且高效的治疗方案。Alto的精准精神病学平台™通过分析脑电图活动、神经认知评估、可穿戴设备数据及其他因素来测量大脑生物标志物，以更好地识别哪些患者更有可能对Alto的产品候选药物产生反应。

Alto’s clinical-stage pipeline includes novel drug candidates in bipolar depression, major depressive disorder, treatment resistant depression (TRD), and schizophrenia, and other mental health conditions. For more information, visit www.altoneuroscience.com or follow Alto on X..

Alto的临床阶段管线包括用于双相抑郁、重度抑郁症、难治性抑郁症（TRD）、精神分裂症及其他心理健康状况的新型候选药物。欲了解更多信息，请访问www.altoneuroscience.com或在X上关注Alto。

Forward-Looking Statements

前瞻性声明

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “expects,” “plans,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words.

本新闻稿可能包含根据1995年《私人证券诉讼改革法案》的安全港条款作出的前瞻性陈述。这些陈述可以通过诸如“预期”、“计划”、“将”等词语以及这些词语的变化或类似表达来识别，旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些词语。

Forward-looking statements in this press release include, but are not limited to, statements regarding Alto’s expectations about the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform (“Platform”); statements regarding Alto’s expectations for the design, progress and results of its ongoing Phase 2 POC trial of ALTO-101 in CIAS; Alto’s ability to recognize the benefits of receiving Fast Track designation, Alto’s expectations with regard to the design and results of its clinical trials.

本新闻稿中的前瞻性声明包括但不限于关于Alto对其产品候选物和精准精神病学平台（“平台”）潜在益处、活性、有效性和安全性的预期声明；关于Alto对其正在进行的ALTO-101二期POC试验在CIAS中的设计、进展和结果的预期声明；Alto实现快速通道指定带来益处的能力；以及Alto对其临床试验设计和结果的预期。

Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the initiation, progress and completion of clinical trials, including the Phase 2 POC trial of ALTO-101, and other important factors, any of which could cause Alto’s actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled “Risk Factors” in each of Alto’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and Alto’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Alto may make with the SEC in the future.

实际结果或事件可能与这些前瞻性陈述中披露的计划、意图和预期有重大差异，原因包括多种因素，包括临床试验（包括ALTO-101的二期概念验证试验）启动、进展和完成过程中固有的不确定性，以及其他重要因素，其中任何一项都可能导致Alto的实际结果与前瞻性陈述中包含的结果不同。这些因素在Alto截至2024年12月31日的财政年度的Form 10-K年报和Alto截至2025年6月30日的财政季度的Form 10-Q季报中的“风险因素”部分有更详细的描述，并已提交给美国证券交易委员会（“SEC”），同时也可能包含在Alto未来向SEC提交的其他文件中。

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Availability of Information on Alto’s Website

Alto网站上信息的可用性

Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website..

Alto 常规使用其投资者关系网站向投资者发布演示文稿及其他重要信息，其中可能包含具有重大影响的内容。因此，Alto 鼓励投资者及其他对 Alto 感兴趣的人士查阅其在投资者关系网站上公开的信息。

Investor and Media Contact:

投资者和媒体联系人：

Nick Smith

尼克·史密斯

investors@altoneuroscience.com

投资者@阿尔托神经科学.com

media@altoneuroscience.com

媒体@阿尔托神经科学.com

Source: altoneuroscience.com

来源：altoneuroscience.com