98% of drugs do not reach the brain, as the blood–brain barrier (BBB) separates peripheral blood circulation from the central nervous system (CNS).

98%的药物无法到达大脑，因为血脑屏障（BBB）将外周血液循环与中枢神经系统（CNS）分隔开来。

Galmed has developed, in collaboration with Barcode Nanotech, a unique proprietary formulation of Aramchol which targets the brain. By crossing the BBB, this new Aramchol formulation could become a disease modifying therapy for unmet chronic CNS diseases.

Galmed与Barcode Nanotech合作开发了一种独特的Aramchol专利配方，该配方靶向大脑。通过穿越血脑屏障（BBB），这种新的Aramchol配方可能成为针对尚未满足需求的慢性中枢神经系统疾病的改良疗法。

Stearoyl-CoA desaturase (SCD1) has been identified as an important therapeutic target for CNS diseases (Parkinson disease and dementia) which are characterized by the aggregation of the protein α-synuclein (αSyn). In-vitro studies have demonstrated that Aramchol effectively down-regulated αSyn-aggregation in a dose dependent manner..

硬脂酰辅酶A去饱和酶（SCD1）已被确定为中枢神经系统疾病（如帕金森病和痴呆）的重要治疗靶点，这些疾病以α-突触核蛋白（αSyn）的聚集为特征。体外研究表明，Aramchol能够以剂量依赖的方式有效下调αSyn的聚集。

RAMAT-GAN, Israel

以色列拉马特甘

,

，

April 9, 2026

2026年4月9日

/PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:

/PRNewswire/ -- Galmed Pharmaceuticals Ltd.（纳斯达克：

GLMD

GLMD

) ('Galmed' or the 'Company'), a clinical-stage biopharmaceutical company for liver, cardiometabolic diseases and GI oncological therapeutics, announced today the breakthrough development of a brain penetrating new formulation of Aramchol. Crossing of the blood-brain barrier (BBB) is an essential step to achieve effective treatment effects in Parkinson disease (PD) and other CNS diseases.

）（“Galmed”或“公司”），一家专注于肝脏、心脑代谢疾病和胃肠道肿瘤治疗的临床阶段生物制药公司，今天宣布了Aramchol一种能穿透大脑的新制剂的突破性进展。穿越血脑屏障（BBB）是实现帕金森病（PD）和其他中枢神经系统疾病有效治疗的关键步骤。

The new Aramchol formulation is characterized by sequestration of the Aramchol in lipid nanoparticles which will be administered by subcutaneous injection for delivery across the BBB..

新的Aramchol制剂的特点是将Aramchol包裹在脂质纳米颗粒中，通过皮下注射给药，以穿越血脑屏障。

This new Aramchol formulation was co-developed by Galmed and Barcode Nanotech, based on Barcode Nanotech's unique and proprietary platform which enables simultaneous screening of hundreds of different nanoparticle formulations in vivo, coupled with AI analysis tools to select the optimal delivery vehicle to the brain..

这种新的Aramchol制剂由Galmed和Barcode Nanotech共同开发，基于Barcode Nanotech独特且专有的平台，该平台能够同时在体内筛选数百种不同的纳米颗粒制剂，并结合人工智能分析工具，以选择最佳的脑部递送载体。

There are currently no disease-modifying therapies available for treatment of PD or related synucleinopathies such as multiple systems atrophy (MSA) and dementia with Lewy bodies (DLB). These diseases are each characterized by presence of Lewy bodies enriched in αSyn protein and are thus collectively known as synucleinopathies.

目前尚无用于治疗帕金森病（PD）或相关突触核蛋白病（如多系统萎缩（MSA）和路易体痴呆（DLB））的疾病修饰疗法。这些疾病均以富含αSyn蛋白的路易小体为特征，因此统称为突触核蛋白病。

Recent evidence from cell-based screens of αSyn toxicity has identified stearoyl-CoA desaturase 1 (SCD1) as a potential target for treatment of synucleinopathies..

最近基于细胞的αSyn毒性筛选证据已将硬脂酰辅酶A去饱和酶1（SCD1）确定为治疗突触核蛋白病的潜在靶点。

Based on the evidence for the role of SCD1 inhibition in mitigating synucleinopathies, Galmed's breakthrough medicinal chemistry work converting Aramchol into a brain-penetrant SCD1 inhibitor position Aramchol as an attractive therapeutic asset for synucleinopathies such as Parkinson disease, multiple systems atrophy (MSA), dementia and other CNS indications of unmet need..

基于抑制SCD1在减轻突触核蛋白病中的作用证据，Galmed突破性的药物化学工作将Aramchol转化为能够穿透大脑的SCD1抑制剂，使Aramchol成为治疗帕金森病、多系统萎缩（MSA）、痴呆症及其他未满足需求的中枢神经系统疾病的有吸引力的治疗选择。

Allen Baharaff, Galmed's Co-founder and CEO, commented: 'The largest challenge in developing innovative CNS therapeutics is delivering these molecules to the brain. I am excited to report today the fruits of our collaboration with Barcode Nanotech, advancing our lead compound Aramchol as a first in class brain penetrating SCD1 inhibitor.

艾伦·巴哈拉夫，Galmed公司的联合创始人兼首席执行官评论道：“开发创新的中枢神经系统治疗药物的最大挑战是将这些分子递送到大脑。我非常高兴地报告我们与Barcode Nanotech合作的成果，推进我们的先导化合物Aramchol成为首个能够穿透大脑的SCD1抑制剂。”

Based on our preliminary in-vitro data which demonstrated that Aramchol dose-dependently down-regulated αSyn-aggregation as well as indicating that the treatment was not associated with toxicity, we believe that treatment with Aramchol could prevent the pathophysiological cascade that leads to αSyn-aggregation which induces a chronic inflammatory state that is associated with PD disease progression and severity.

基于我们初步的体外数据，这些数据表明Aramchol能够以剂量依赖性方式下调αSyn聚集，并且表明该治疗未伴随毒性，我们相信使用Aramchol进行治疗可以预防导致αSyn聚集的病理生理级联反应，这种聚集会引发与帕金森病（PD）疾病进展和严重程度相关的慢性炎症状态。

Subject to the regulatory advice we are now seeking, we are planning to advance Aramchol to a PoC Ph1b/2 studies in PD patients in H2 2026.'.

根据我们目前正在寻求的监管建议，我们计划在2026年下半年将Aramchol推进到PD患者的PoC Ph1b/2研究。

Ronen Eavri, Co-founder & CEO of Barcode Nanotech, commented: 'Barcode Nanotech has developed a library of novel lipids for RNA and DNA, LNP-based delivery, through a unique in vivo & AI-based screening platform which allow simultaneously screening of hundreds of different nanoparticle formulations.

Barcode Nanotech 的联合创始人兼首席执行官罗南·埃夫里评论道：“Barcode Nanotech 已经开发出一个用于 RNA 和 DNA、基于 LNP 递送的新型脂质库，通过一个独特的体内和基于人工智能的筛选平台，可以同时筛选数百种不同的纳米颗粒制剂。”

Based on our proprietary platform and lipids library we have identified a unique formulation of Aramchol to cross the BBB and deliver the molecule to the brain. We look forward to continuing our collaboration with Galmed to develop target-specific selective delivery vehicles of Aramchol to enable precise target-site activity and release of this promising drug.'.

基于我们的专有平台和脂质库，我们已经确定了Aramchol的一种独特配方，可以穿越血脑屏障并将该分子递送到大脑。我们期待继续与Galmed合作，开发针对特定目标的Aramchol选择性递送载体，以实现该药物在目标位点的精确活性和释放。

About Galmed Pharmaceuticals Ltd.:

关于Galmed制药有限公司：

We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver diseases, and continue to actively advance Aramchol for the treatment of combination therapy for NASH. We are also seeking to develop Aramchol for certain oncological indications outside of NASH and fibrosis.

我们是一家专注于Aramchol开发的生物制药公司。我们几乎专注于将Aramchol开发用于治疗肝病，并继续积极推进Aramchol作为NASH联合疗法的治疗药物。我们还寻求将Aramchol开发用于NASH和纤维化之外的某些肿瘤适应症。

In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development..

此外，作为我们增长战略的一部分，我们正在积极寻求机会，扩大和多元化我们的产品管线，特别是针对心代谢适应症和其他与我们在药物开发核心专长相契合的创新候选产品。

About Barcode Nanotech Ltd.:

关于条形码纳米技术有限公司：

Barcode Nanotech develops delivery solutions for RNA & DNA therapies through a unique multiplexed discovery platform. The Company's proprietary NeoRNA™ Targeting Technology enables efficient discovery and optimization of lipid-based nanoparticles (LNPs) through

条码纳米技术公司通过独特的多重发现平台，为RNA和DNA疗法开发递送解决方案。该公司专有的NeoRNA™靶向技术能够通过高效发现和优化基于脂质的纳米颗粒（LNPs）。

in silico

计算机模拟

&

&

in vivo

体内

mass-screening. The solution combines the design of thousands of new lipids and LNPs, advanced AI tools and

大规模筛查。该解决方案结合了数千种新型脂质和脂质纳米颗粒（LNP）的设计，先进的AI工具以及

in vivo

体内

barcoding-based biodistribution analysis at a single cell resolution. Using this platform, Barcode has developed unique LNPs that can direct RNA and other therapies to cells in the brain, kidney, lungs and additional target organs. The company has an in-house lead drug development program and concurrently collaborates with biopharma companies to develop new therapies..

基于条形码的单细胞分辨率生物分布分析。通过该平台，Barcode 开发了独特的脂质纳米颗粒（LNP），可将 RNA 和其他疗法引导至大脑、肾脏、肺部及其他目标器官的细胞。公司拥有内部主导的药物开发项目，同时与生物制药公司合作开发新疗法。

Forward-Looking Statements:

前瞻性声明：

Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements.

前瞻性声明涉及截至作出该声明之日预期或预计的事件、活动、趋势或结果。由于前瞻性声明涉及尚未发生的事项，因此这些声明本质上受到风险和不确定性的制约，可能导致我们的实际结果与前瞻性声明中表达或暗示的任何未来结果存在重大差异。

Forward-looking statements may include, but are not limited to, statements relating to the potential synergistic effect of Aramchol, Stivarga.

前瞻性声明可能包括但不限于与Aramchol、Stivarga潜在协同效应相关的声明。

®

®

and Metformin as a new fixed-dose combination treatment, the expected timing of clinical trials, future clinical development and creating value for investors and stakeholders. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S.

以及将Metformin作为新的固定剂量组合治疗，临床试验的预期时间、未来的临床开发和为投资者及利益相关者创造价值。许多因素可能导致我们的实际活动或结果与前瞻性陈述中预期的活动和结果存在重大差异，包括但不限于Aramchol或任何其他候选产品在非酒精性脂肪性肝炎（NASH），也称为代谢功能障碍相关脂肪性肝炎（MASH）及纤维化以外适应症或联合疗法中的开发和批准；Aramchol或我们开发的任何其他候选产品的任何临床前或临床试验的时间和成本；完成并获得任何临床前或临床试验的有利结果；美国监管机构针对Aramchol或任何其他候选产品采取的行动。

Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, or any other product candidate; third-party payor reimbursement for Aramchol, or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and pati.

美国食品药品监督管理局（FDA）或欧洲药品管理局（EMA），包括但不限于对上市许可申请的受理、对该申请的审查与批准，以及如果获得批准，所批准适应症和标签的范围；Aramchol及任何未来候选产品的商业发布和未来销售；我们在寻求推广产品的国家中遵守所有适用的上市后监管要求的能力；我们为Aramchol或任何其他候选产品实现有利定价的能力；第三方支付方对Aramchol或任何其他候选产品的报销；我们对预期资本需求和额外融资需求的估计；医生和患者对Aramchol或任何其他候选产品的市场接受度。

Logo:

标志：

https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg

https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg

SOURCE Galmed Pharmaceuticals Ltd.

来源：Galmed Pharmaceuticals Ltd.

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