MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced the completion of enrollment in its Phase 2b study of ALTO-100 in adults with major depressive disorder (MDD).

加利福尼亚州山景城讯（商业新闻短讯）--Alto Neuroscience，Inc.（“Alto”）（纽约证券交易所：ANRO）是一家临床阶段的生物制药公司，专注于开发治疗神经精神疾病的新型精密药物，今天宣布完成其针对重度抑郁症（MDD）成年人的Alto-100 2b期研究。

Topline results from this study are expected to be reported in October 2024..

这项研究的最终结果预计将于2024年10月报告。。

“The completion of enrollment in this study marks an important achievement,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “We look forward to reporting topline results later this year, which, if positive, will propel us into Phase 3 and ultimately bring us one step closer to realizing the potential of precision psychiatry.”.

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：“这项研究的完成标志着一项重要成就。”。“我们期待着在今年晚些时候报告最终结果，如果是积极的，这将推动我们进入第三阶段，并最终使我们离实现精确精神病学的潜力更近一步。”。

The Phase 2b study is a randomized, double-blind, placebo-controlled study evaluating ALTO-100 in adults with major depressive disorder (MDD). The study is designed to determine the efficacy of ALTO-100 in MDD patients defined by an objective cognitive biomarker assessed prior to randomization. The Phase 2b study is enriched for patients exhibiting the predictive cognitive marker but also includes patients without the marker.

2b期研究是一项随机，双盲，安慰剂对照研究，评估成人重度抑郁症（MDD）患者的ALTO-100。该研究旨在确定ALTO-100在MDD患者中的疗效，该患者由随机化前评估的客观认知生物标志物定义。2b期研究丰富了表现出预测性认知标记的患者，但也包括没有标记的患者。

The primary endpoint is the change from baseline to the end of the 6-week double-blind treatment period on the Montgomery-Åsberg Depression Rating Scale (MADRS), which is the standard regulatory endpoint in depression, in the prospectively identified patient population based on a specific memory deficit.

主要终点是蒙哥马利-Åsberg抑郁评定量表（MADRS）从基线到6周双盲治疗期结束的变化，这是抑郁症的标准调节终点，在前瞻性确定的患者人群中基于特定的记忆缺陷。

The study was conducted across 34 sites in the U.S. and enrolled 300 adults with MDD. For more information about the ongoing study, visit ClinicalTrials.gov (NCT05712187)..

这项研究在美国的34个地点进行，招募了300名患有MDD的成年人。有关正在进行的研究的更多信息，请访问ClinicalTrials.gov（NCT05712187）。。

“Major depressive disorder is among the most prevalent CNS conditions and is a leading cause of disability worldwide,” said Adam Savitz, M.D., Ph.D., chief medical officer of Alto. “If we are successful, new targeted therapies like ALTO-100 represent the future of psychiatric care. We are pleased with the receptivity to our neurocognitive test.

“重度抑郁症是最常见的中枢神经系统疾病之一，也是全球残疾的主要原因，”Alto首席医学官AdamSavitz医学博士说。“如果我们取得成功，像ALTO-100这样的新靶向治疗代表了精神病护理的未来。我们对神经认知测试的接受性感到满意。

The execution of this study demonstrates the potential for this test to be implemented broadly in clinical practice. We are grateful to the patients in the study, physicians, trial site staff, and partnerships with advocacy organizations for their efforts in helping us to reach this point.”.

这项研究的实施证明了该测试在临床实践中广泛实施的潜力。我们感谢研究中的患者，医生，试验现场工作人员以及与倡导组织的合作伙伴，感谢他们帮助我们达到这一点。”。

Alto Investor Day Focused on ALTO-100 in MDD

Alto Investor Day关注MDD中的Alto-100

The company plans to host an investor day on September 9, 2024 focused on ALTO-100. The Company expects to provide information regarding the baseline characteristics of study participants, mechanistic and clinical rationale for ALTO-100, and the predictive cognitive test being used to select patients in the Phase 2b study.

该公司计划于2024年9月9日举办投资者日，重点关注ALTO-100。该公司希望提供有关研究参与者的基线特征，ALTO-100的机制和临床原理以及用于选择2b期研究患者的预测性认知测试的信息。

More details regarding the investor day are forthcoming and will be made available on the Company’s investor relations website..

有关投资者日的更多详细信息即将发布，并将在公司的投资者关系网站上发布。。

About ALTO-100

关于ALTO-100

ALTO-100 is a novel oral small molecule that has shown evidence of a pro-neurogenesis/neuroplasticity mechanism of action and first-in-class therapeutic potential. ALTO-100 is being developed for major depressive disorder (MDD). In a Phase 2a clinical trial, ALTO-100 demonstrated favorable safety and tolerability, and significantly greater treatment response in patients with an objectively defined cognitive biomarker..

ALTO-100是一种新型口服小分子，已显示出促神经发生/神经可塑性作用机制和一流治疗潜力的证据。ALTO-100正在开发用于重度抑郁症（MDD）。在一项2a期临床试验中，ALTO-100在具有客观定义的认知生物标志物的患者中表现出良好的安全性和耐受性，并且显着提高了治疗反应。。

About the ALTO-100 Cognitive Biomarker

关于ALTO-100认知生物标志物

Alto leverages its Precision Psychiatry Platform™ to identify brain-based biomarkers as predictors of response to medication. The predictive biomarker identified, and prospectively replicated, for ALTO-100 is a test of verbal memory, or the ability to recall lists of unrelated words. Verbal memory is a direct measure of hippocampal neuroplasticity; therefore, selecting patients based on poor performance on this test provides a clear biological link between the proposed pro-plasticity mechanism of ALTO-100 and this characteristic of responsive patients.

Alto利用其Precision Psychiatry Platform™识别基于大脑的生物标志物作为药物反应的预测因子。ALTO-100识别并前瞻性复制的预测性生物标志物是对言语记忆或回忆不相关单词列表的能力的测试。言语记忆是海马神经可塑性的直接量度；因此，根据该测试的不良表现选择患者，可以在拟议的ALTO-100促塑机制与反应性患者的这一特征之间提供明确的生物学联系。

The test used to compute the biomarker score is Alto’s digital adaptation of a well validated instrument that has been used in clinical practice for assessing memory for more than 80 years and is highly test-retest reliable. The web-based memory test is self-administered and can be completed by the patient in less than 20 minutes in any setting, including at home.

用于计算生物标志物评分的测试是Alto对经过充分验证的仪器的数字改编，该仪器已在临床实践中用于评估记忆80多年，并且具有高度的重测可靠性。基于网络的记忆测试是自我管理的，患者可以在任何情况下（包括在家中）在不到20分钟的时间内完成。

This convenient, reliable, and efficient test enables high-quality data collection at a broad clinical scale..

这种方便，可靠，高效的测试可以在广泛的临床规模上进行高质量的数据收集。。

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..

Alto的临床阶段管道包括抑郁症，创伤后应激障碍，精神分裂症和其他心理健康状况的新型候选药物。有关更多信息，请访问www.altoneuroscience.com或关注X上的Alto。。