LOS ALTOS, Calif.--(BUSINESS WIRE)--Alto Neuroscience, Inc. today announced positive results from its Phase 2a study of ALTO-300 at the 62nd Annual Meeting of the American College of Neuropsychopharmacology (ACNP), demonstrating clinically meaningful improvements and favorable safety and tolerability in patients with major depressive disorder (MDD).

加利福尼亚州洛斯阿尔托斯-（商业线）-Alto Neuroscience，Inc。今天在美国神经心理药理学学院（ACNP）第62届年会上宣布了Alto-300 2a期研究的积极成果，证明了临床上有意义的改进和重度抑郁障碍（MDD）患者有利的安全性和耐受性。

Following administration of ALTO-300, patients characterized by an electroencephalogram (EEG) biomarker demonstrated robust clinical improvement in depression symptoms and higher response rates, as measured by the Montgomery–Åsberg Depression Rating Scale (MADRS), compared to patients without the EEG biomarker.

施用ALTO-300后，与没有EEG生物标志物的患者相比，以蒙哥马利-Åsberg抑郁量表（MADRS）测量的以脑电图（EEG）生物标志物为特征的患者表现出抑郁症状的强烈临床改善和更高的应答率。

These results support the potential of ALTO-300 as a novel treatment for MDD. The company has initiated a Phase 2b study evaluating ALTO-300 in 200 patients with MDD, which is expected to read out in the first half of 2025..

这些结果支持ALTO-300作为MDD新型治疗方法的潜力。该公司已启动一项2b期研究，评估200名MDD患者的ALTO-300，预计将于2025年上半年公布。。

“Our conviction in the promise of precision medicine for the brain is bolstered by these results,” said Amit Etkin, M.D., Ph.D., founder, president, and chief executive officer of Alto Neuroscience. “Data from the ALTO-300 study showcase the potential of targeting patients’ underlying neurobiology to achieve clear clinical benefit and further validate our precision drug development approach.”.

阿尔托神经科学公司创始人，总裁兼首席执行官Amit Etkin博士说：“这些结果支持了我们对精准医学承诺的信念。“来自ALTO-300研究的数据展示了针对患者潜在神经生物学的潜力，以获得明确的临床益处并进一步验证我们的精确药物开发方法。”。

The study was an 8-week clinical trial to evaluate potential predictive biomarkers for efficacy and safety of ALTO-300 as an adjunctive treatment in patients with MDD who experienced inadequate response to an antidepressant. 239 patients between the ages of 18-74 years old were enrolled in the study, staying on a background antidepressant while ALTO-300 was added as a new treatment.

该研究是一项为期8周的临床试验，旨在评估ALTO-300作为MDD患者对抗抑郁药反应不足的辅助治疗的有效性和安全性的潜在预测性生物标志物。239名年龄在18-74岁之间的患者参加了这项研究，停留在背景抗抑郁药上，而ALTO-300作为一种新的治疗方法加入。

110 of these patients underwent an EEG at baseline. Alto used a rigorous machine learning-driven data science approach, which centrally requires prospective replication of a biomarker’s ability to predict a drug’s antidepressant clinical efficacy in an independent group of patients. Taking this approach, likely drug responders can be found while avoiding false discovery.

这些患者中有110例在基线时接受了脑电图检查。Alto使用严格的机器学习驱动的数据科学方法，该方法集中需要前瞻性复制生物标志物在独立患者组中预测药物抗抑郁药临床疗效的能力。采用这种方法，可以在避免错误发现的同时找到可能的药物反应者。

The primary analysis was on prediction of change in depressive symptoms, as measured by the MADRS, at week 4..

主要分析是预测MADRS在第4周测量的抑郁症状的变化。。

Topline results from the ALTO-300 Phase 2a study include:

ALTO-300 2a期研究的主要结果包括：

A reproducible, readily scalable, and easily administered machine learning-derived EEG biomarker was identified. Alto is leveraging this biomarker and prospective patient identification with EEG in its ongoing Phase 2b trial of ALTO-300.

确定了可重复的，易于扩展的且易于管理的机器学习衍生的EEG生物标志物。Alto正在Alto-300正在进行的2b期临床试验中利用这种生物标志物和EEG的前瞻性患者识别。

Across the entire dataset, including the initial discovery data set and the independent test data set, the biomarker-characterized patients (n=55) demonstrated an 8.3-point mean MADRS reduction compared to 5.7 points in the patient group without the biomarker profile (n=48) starting at week 1 (p=0.03, d=0.37) and improved through week 8 of measurement (-17 vs.

在整个数据集中，包括初始发现数据集和独立测试数据集，生物标志物表征的患者（n=55）表现出8.3点平均MADRS降低，而没有生物标志物谱的患者组为5.7点（n=48）从第1周开始（p=0.03，d=0.37），并在第8周测量时有所改善（-17 vs。

-12.3, p=0.002, d=0.59)..

-12.3，p=0.002，d=0.59）。。

In the independent test data set, the biomarker-characterized MDD patient group (n=24) demonstrated an 11-point mean MADRS reduction compared to 7.8-points in the patient group without the biomarker profile (n=21) starting at week 4 (p=0.05, d=0.40), improving further through week 8 of measurement (-16.4 vs.

在独立测试数据集中，生物标志物表征的MDD患者组（n=24）显示11点平均MADRS降低，而没有生物标志物概况的患者组（n=21）从第4周开始（p=0.05，d=0.40），通过第8周的测量进一步改善（-16.4 vs。

-11.6; p=0.03, d=0.63)..

-11.6;p=0.03，d=0.63）。。

Significantly more biomarker-characterized patients (n=55) than patients without the biomarker (n=50) achieved clinical response (defined as ≥50% reduction in depression symptoms) at week 4 (47% vs. 27%) and week 6 of treatment (58% vs. 34%), with the trend continuing at week 8 (62% vs. 47%).

在第4周（47%对27%）和第6周，显着更多的生物标志物表征患者（n=55）比没有生物标志物的患者（n=50）达到临床反应（定义为抑郁症状减少≥50%）。治疗（58%对34%），趋势持续到第8周（62%对47%）。

The predictive biomarker is specific to patients receiving ALTO-300, as it is not predictive of response in patients taking either placebo or standard-of-care SSRI/SNRIs based on data from separate studies in which EEG measurements allowed Alto to differentiate between patients with or without this EEG biomarker..

预测性生物标志物对于接受ALTO-300的患者是特异性的，因为它不能预测服用安慰剂或标准护理SSRI/SNRIs的患者的反应，这是基于单独研究的数据，其中EEG测量允许ALTO区分患有或没有这种EEG生物标志物。。

ALTO-300 demonstrated a favorable safety and tolerability profile with no unexpected adverse effects.

ALTO-300表现出良好的安全性和耐受性，没有意外的副作用。

About Alto Neuroscience

关于阿尔托神经科学

Alto Neuroscience is pioneering precision psychiatry by developing targeted medicines designed to help patients get better faster. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive task performance, wearable data, and other factors to match each patient with the right Alto product candidate.

Alto Neuroscience通过开发旨在帮助患者更快地获益的靶向药物开创精确精神病学。奥托的精准精神病学平台™通过分析脑电图活动，神经认知任务表现，可穿戴数据和其他因素来测量大脑生物标志物，以使每位患者与正确的Alto产品候选人相匹配。

The company’s work in validating brain-based biomarkers has resulted in a multiple modality approach that supports robust drug-response predictions. 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 us on X (Twitter)..

该公司在验证基于大脑的生物标志物方面的工作已经产生了支持稳健的药物反应预测的多模式方法。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。欲了解更多信息，请访问www.altoneuroscience.com或在X（Twitter）上关注我们。。