LOS ALTOS, Calif.--(BUSINESS WIRE)--Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today announced the initiation of a Phase 2 double-blind, placebo-controlled study of its transdermal formulation of ALTO-101, a novel PDE4 inhibitor in development for the treatment of cognitive impairment associated with schizophrenia (CIAS).

加利福尼亚州洛斯阿尔托斯市——（商业新闻短讯）——阿尔托神经科学公司（Alto Neuroscience，Inc.）（纽约证券交易所代码：ANRO）今天宣布开始对其Alto-101透皮制剂进行2期双盲安慰剂对照研究，Alto-101是一种新型PDE4抑制剂，正在开发中，用于治疗与精神分裂症相关的认知障碍（CIAS）。

Alto expects to report top-line data from the Phase 2 study in the second half of 2025..

Alto预计将在2025年下半年报告第二阶段研究的顶线数据。。

“We are excited to initiate our sixth Phase 2 study as a company, across our pipeline programs, as we continue to redefine mental healthcare with Alto’s Precision Psychiatry Platform,” said Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience. “Cognitive impairment is disabling in many psychiatric disorders including schizophrenia, depression, and neurodegenerative diseases.

Alto Neuroscience创始人兼首席执行官、医学博士阿米特·埃特金（Amit Etkin）表示：“我们很高兴作为一家公司，通过我们的管道项目启动第六阶段2研究，因为我们将继续利用Alto的精准精神病学平台重新定义精神保健。”。。

ALTO-101 has the potential to address the cognitive aspects of these diseases with a known pro-cognitive mechanism, while also overcoming the side effects typically associated with PDE4 inhibitors. We look forward to completing this proof-of-concept study, as we believe ALTO-101 may benefit patients with CIAS and potentially become an important therapeutic option for a broad range of indications.”.

ALTO-101有可能通过已知的促认知机制解决这些疾病的认知方面，同时也克服了通常与PDE4抑制剂相关的副作用。我们期待着完成这项概念验证研究，因为我们相信ALTO-101可能会使CIA患者受益，并可能成为广泛适应症的重要治疗选择。”。

Alto recently completed a Phase 1 study of ALTO-101 in healthy adults, demonstrating positive effects on cognition and electroencephalography (EEG) measures relevant to cognitive function. Alto’s novel transdermal formulation of ALTO-101 exhibited greater systemic drug exposure than orally administered ALTO-101 while also demonstrating a reduction in typical class-related adverse events..

Alto最近在健康成年人中完成了Alto-101的第一阶段研究，证明了对认知功能和与认知功能相关的脑电图（EEG）测量的积极影响。Alto的新型透皮制剂Alto-101比口服Alto-101表现出更大的全身药物暴露，同时也证明了典型的类相关不良事件的减少。。

The Phase 2 study announced today consists of a cross-over double-blind, placebo-controlled, dose-escalating treatment with ALTO-101 and placebo in patients with CIAS. Alto expects to enroll approximately 70 adult participants between 21-55 years old with schizophrenia and a demonstrable level of cognitive impairment.

今天宣布的第二阶段研究包括对CIA患者使用ALTO-101和安慰剂进行交叉双盲，安慰剂对照，剂量递增治疗。。

Alto will evaluate the effects of ALTO-101 on EEG markers relevant to cognitive function and will also explore its effects on cognitive performance. The primary outcome in the study is the effect of ALTO-101 on theta band activity as measured using EEG at the end of each dose period..

Alto将评估Alto-101对与认知功能相关的脑电图标记的影响，并探讨其对认知表现的影响。该研究的主要结果是ALTO-101对每个剂量期结束时使用EEG测量的θ带活性的影响。。

Alto recently presented data at the Society of Biological Psychiatry (SOBP) Annual Meeting demonstrating that theta band activity has both the greatest correlation with cognitive function in patients with schizophrenia among a comprehensive set of EEG measures as well as greatest case-control sensitivity.

Alto最近在生物精神病学学会（SOBP）年会上提交的数据表明，在一系列全面的脑电图测量中，θ波段活动与精神分裂症患者的认知功能具有最大的相关性，并且具有最大的病例对照敏感性。

The findings on these measures, which were prospectively replicated, support the suitability of the primary outcome measure being evaluated in the present study to demonstrate robust proof-of-concept of ALTO-101 as a potential treatment for CIAS..

前瞻性复制的这些措施的发现支持了本研究中评估的主要结局指标的适用性，以证明ALTO-101作为CIA潜在治疗方法的强大概念证明。。

About ALTO-101

关于ALTO-101

ALTO-101 is a novel small molecule PDE4 inhibitor being developed for cognitive impairment associated with schizophrenia, a disease state defined by negative and cognitive symptoms with no currently available targeted treatments. Through a proprietary transdermal delivery system, ALTO-101 is designed to provide steady state concentrations to improve drug safety, tolerability, and pharmacokinetics.

ALTO-101是一种新型小分子PDE4抑制剂，正在开发用于与精神分裂症相关的认知障碍，精神分裂症是一种由阴性和认知症状定义的疾病状态，目前尚无针对性治疗方法。通过专有的透皮给药系统，ALTO-101旨在提供稳态浓度，以改善药物安全性，耐受性和药代动力学。

The proprietary transdermal delivery system for ALTO-101 has been developed in partnership with MEDRx. In Phase 1 clinical trials, ALTO-101 demonstrated human brain penetration, robust CNS-relevant pharmacodynamic effects, and was well tolerated across therapeutically relevant dose ranges..

ALTO-101专有透皮给药系统是与MEDRx合作开发的。在第一阶段临床试验中，ALTO-101表现出人脑渗透，强大的中枢神经系统相关药效学作用，并且在治疗相关剂量范围内具有良好的耐受性。。

About Cognitive Impairment Associated with Schizophrenia

关于与精神分裂症相关的认知障碍

Schizophrenia is a serious, persistent, and often disabling mental illness impacting how a person thinks, feels, and behaves. The illness affects nearly 24 million people worldwide, including 2.8 million people in the United States. It is characterized by multiple symptom domains, including: positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawal from others), and cognitive impairment (deficits in memory, concentration, and decision-making).

精神分裂症是一种严重的、持续性的、经常致残的精神疾病，会影响一个人的思维、感觉和行为。这种疾病影响了全世界近2400万人，其中包括美国280万人。它的特征是多个症状领域，包括：阳性症状（幻觉和妄想），阴性症状（难以享受生活和退出他人）和认知障碍（记忆力，注意力和决策能力不足）。

A large proportion of people living with schizophrenia struggle to live independent lives and often rely on life-long caregiver support. Approximately 70% of people with schizophrenia have cognitive impairment associated with the illness, and there are currently no approved treatments to specifically address the negative and cognitive symptoms associated with schizophrenia..

精神分裂症患者中有很大一部分人难以独立生活，往往依赖终身护理人员的支持。大约70%的精神分裂症患者患有与疾病相关的认知障碍，目前还没有批准的治疗方法来专门解决与精神分裂症相关的负面和认知症状。。

About Alto Neuroscience

关于Alto神经科学

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，其使命是通过利用神经生物学开发个性化和高效的治疗选择来重新定义精神病学。Alto的Precision Psychiatry Platform™通过分析脑电图活动、神经认知评估、可穿戴数据和其他因素来测量大脑生物标志物，以更好地确定哪些患者更有可能对Alto候选产品产生反应。

Alto’s clinical-stage pipeline includes novel drug candidates in depression, PTSD, schizophrenia, and other mental health conditions. For more information, visit www.altoneuroscience.com or follow Alto on X..

。有关更多信息，请访问www.altoneuroscience.com或关注X上的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 “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “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》安全港条款所作的前瞻性声明。这些陈述可以用“目标”、“预期”、“相信”、“可能”、“估计”、“预期”、“预测”、“目标”、“打算”、“可能”、“计划”、“可能”、“潜在”、“寻求”、“将”等词语以及这些词语的变体或旨在识别前瞻性陈述的类似表达来识别，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 for the timing, design, and results of the ALTO-101 study, and the number of subjects to be enrolled in the study. 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 design, initiation, progress and completion of the ALTO-101 study and clinical development of ALTO-101; the risk that Alto may not achieve the targeted enrollment in the ALTO-101 study or that enrollment may take longer than expected; the availability and timing of results from the ALTO-101 study; 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 Alto’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Alto may make with the SEC in the future.

本新闻稿中的前瞻性声明包括但不限于关于Alto对Alto-101研究的时间，设计和结果的期望以及将参加研究的受试者数量的声明。由于各种因素，包括ALTO-101研究的设计、启动、进展和完成以及ALTO-101的临床开发所固有的不确定性，实际结果或事件可能与这些前瞻性声明中披露的计划、意图和期望存在重大差异；Alto可能无法实现Alto-101研究的目标入学率或入学时间可能比预期更长的风险；ALTO-101研究结果的可用性和时间安排；以及其他重要因素，这些因素中的任何一个都可能导致Alto的实际业绩与前瞻性报表中所包含的结果不同，在Alto向美国证券交易委员会（“SEC”）提交的截至2024年3月31日财政季度的表10-Q季报中题为“风险因素”的部分以及Alto未来可能向SEC提交的其他文件中有更详细的描述。

Any forward-looking statements contained in this press release speak only as of.

本新闻稿中包含的任何前瞻性声明仅在以下日期发表。