Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced the initiation of a Phase 2 clinical trial evaluating ABX-002, its highly potent, oral, thyroid hormone beta receptor (TRβ) selective agonist, as an adjunctive treatment in adults with bipolar depression.

Autobahn Therapeutics是一家为神经精神疾病和神经免疫疾病患者开发恢复性治疗的生物技术公司，今天宣布开始进行2期临床试验，评估其高效口服甲状腺激素β受体（TRβ）选择性激动剂ABX-002作为双相抑郁症成人的辅助治疗。

The Phase 2 trial aims to establish biological and clinical proof-of-concept for ABX-002 in bipolar depression and will inform Autobahn’s further clinical development strategy..

第二阶段试验旨在为双相抑郁症中的ABX-002建立生物学和临床概念验证，并将为高速公路的进一步临床开发策略提供信息。。

“Bipolar depression is one of the most prevalent and difficult-to-treat psychiatric conditions due to a host of burdensome symptoms,” said Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at University of Toronto. “People living with bipolar disorder often experience prolonged periods of depression, many of whom are not adequately benefiting from, or have had difficulties tolerating, existing treatments.

多伦多大学精神病学和药理学教授罗杰·麦金太尔（RogerMcIntyre）医学博士说：“由于一系列繁重的症状，双相抑郁是最普遍和最难治疗的精神疾病之一。”。“患有双相情感障碍的人经常会经历长时间的抑郁症，其中许多人没有充分受益于现有的治疗方法，或者难以忍受现有的治疗方法。

For decades, preclinical and clinical evidence has supported the effectiveness of thyroid hormone as an adjunctive treatment in adults living with bipolar depression, providing the basis for rigorously evaluating an optimized, brain-targeted, potent and selective TRβ agonist which could serve as a highly promising therapeutic option in the future.”.

几十年来，临床前和临床证据支持甲状腺激素作为双相抑郁症患者辅助治疗的有效性，为严格评估优化的，脑靶向的，有效的和选择性的TRβ激动剂提供了基础，这可能是一种非常有希望的治疗选择。未来“。

The Phase 2 open-label trial will study ABX-002 as an adjunctive treatment in 30 adult patients with depressive episodes associated with bipolar I and bipolar II disorder and will utilize neuroimaging assessments and validated clinical scales to evaluate changes in metabolites associated with brain energy metabolism and improvements in depressive symptoms.

第二阶段开放标签试验将研究ABX-002作为30名患有双相I型和双相II型障碍相关抑郁发作的成年患者的辅助治疗，并将利用神经影像学评估和经过验证的临床量表来评估与脑能量代谢相关的代谢物的变化和抑郁症状的改善。

The primary endpoints will be to assess the correlation of change from baseline of nucleoside triphosphate (NTP) and phosphocreatine (PCr) in the brain, as determined by phosphorus magnetic resonance spectroscopy imaging (.

主要终点将是评估大脑中核苷三磷酸（NTP）和磷酸肌酸（PCr）从基线变化的相关性，这是通过磷磁共振波谱成像确定的。

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P-MRS), with percent change in the Hamilton Depression Rating Scale-17 (HAMD-17) over six weeks of dosing, respectively. Key secondary and exploratory endpoints will evaluate changes from baseline in the HAMD-17, HAMD-29, as well as other neuroimaging assessments, including brain activity as measured by resting state functional magnetic resonance imaging (rs-fMRI).

P-MRS），汉密尔顿抑郁量表-17（HAMD-17）在给药六周内分别有百分比变化。关键的次要和探索性终点将评估HAMD-17，HAMD-29以及其他神经影像学评估（包括通过静息状态功能磁共振成像（rs-fMRI）测量的大脑活动）相对于基线的变化。

Autobahn anticipates reporting topline data from this study in the second half of 2025..

Autobahn预计将在2025年下半年报告这项研究的主要数据。。

“We are thrilled to initiate this Phase 2 trial of ABX-002, which we believe has the potential to reshape the treatment paradigm for bipolar depression, particularly as an adjunctive therapy for bipolar patients who do not experience adequate relief with their current antidepressant,” said Gudarz Davar, M.D., Executive Vice President, Head of Research and Development for Autobahn Therapeutics.

Autobahn Therapeutics执行副总裁兼研发负责人Gudarz Davar医学博士说：“我们很高兴启动ABX-002的第二阶段试验，我们认为它有可能重塑双相抑郁的治疗模式，特别是作为双相抑郁患者的辅助治疗，这些患者目前的抗抑郁药没有得到充分缓解。”。

“The clinical evidence generated to date for ABX-002 supports its promise as a centrally-active, differentiated thyromimetic, with a potentially favorable safety profile. This trial initiation expands our clinical depression program, and with our AMPLIFY trial in MDD also underway, sets up 2025 to be a transformational year with two Phase 2 trial readouts, bringing us markedly closer to our goal of addressing the unmet needs of patients living with depression worldwide.”.

“迄今为止，ABX-002产生的临床证据支持其作为一种中枢活性，分化型甲状腺模拟药物的前景，具有潜在的良好安全性。这项试验的启动扩大了我们的临床抑郁症计划，随着我们在MDD中的AMPLIFY试验也在进行中，2025年将成为一个转型年，有两个阶段的2期试验读数，使我们明显接近我们解决全球抑郁症患者未满足需求的目标。”。

ABX-002 is also being evaluated in the company’s ongoing

ABX-002也正在公司的持续评估中

AMPLIFY Phase 2 trial

放大2期试验

as an adjunctive treatment for patients with major depressive disorder (MDD), with topline data expected in the second half of 2025.

作为重度抑郁症（MDD）患者的辅助治疗，预计2025年下半年将有topline数据。

About Autobahn Therapeutics

关于Autobahn Therapeutics

Autobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neuroimmunologic clinical candidates leveraging its brain-targeting chemistry platform. Autobahn aims to unlock new therapeutic opportunities through precision tuning of CNS exposure, pursuing validated clinical and biologic targets, and guiding development with biomarkers.

Autobahn Therapeutics是一家生物技术公司，利用其大脑靶向化学平台开发神经精神病学和神经免疫学临床候选产品组合。Autobahn旨在通过精确调整中枢神经系统暴露，追求经过验证的临床和生物学目标，并指导生物标志物的开发，从而开启新的治疗机会。

The company’s pipeline is led by ABX-002, a thyroid hormone receptor beta (TRβ) agonist being developed as a potential adjunctive treatment for people with major depressive disorder and bipolar disorder depression. Autobahn Therapeutics is based in San Diego. For more information, visit .

该公司的管道由ABX-002领导，ABX-002是一种甲状腺激素受体β（TRβ）激动剂，正在开发中，作为重度抑郁症和双相情感障碍抑郁症患者的潜在辅助治疗药物。Autobahn Therapeutics总部位于圣地亚哥。有关更多信息，请访问。

About ABX-002

关于ABX-002

ABX-002 is an orally administered, potent and selective thyroid hormone beta receptor (TRβ) agonist designed to enhance the CNS benefits of thyroid hormone biology while also reducing the peripheral liabilities of synthetic thyroid hormone (e.g., triiodothyronine, T3), a treatment which has shown efficacy in numerous placebo-controlled human studies across MDD and bipolar disorder depression.

ABX-002是一种口服，有效和选择性的甲状腺激素β受体（TRβ）激动剂，旨在增强甲状腺激素生物学对中枢神经系统的益处，同时降低合成甲状腺激素（如三碘甲状腺原氨酸，T3）的外周负荷，这种治疗方法已在许多针对MDD和双相情感障碍抑郁症的安慰剂对照人体研究中显示出疗效。

Thyroid hormone agonism has demonstrated activity on cellular energy metabolism pathways, which play an important role on the regulation of brain bioenergetics and may be uniquely suited to address symptoms of atypical depression, a highly prevalent and underserved sub-population of MDD. In nonclinical and clinical studies, ABX-002 has demonstrated optimized PK properties, target engagement in brain regions associated with depression, and an attractive safety and tolerability profile..

甲状腺激素激动剂已证明对细胞能量代谢途径具有活性，这在调节大脑生物能量学方面起着重要作用，并且可能特别适合解决非典型抑郁症的症状，非典型抑郁症是MDD的一种高度流行且服务不足的亚群。在非临床和临床研究中，ABX-002已经证明了优化的PK特性，与抑郁症相关的大脑区域的目标参与，以及有吸引力的安全性和耐受性。。