WILMINGTON, Del.

威尔明顿，德拉瓦州

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，

April 2, 2026

2026年4月2日

/PRNewswire/ -- Earendil Labs, an AI-driven biotechnology company advancing next-generation biologics, today announced the first patient has been dosed in a Phase IIa clinical trial of HXN-1001, a half-life extended anti-TL1A antibody, in patients with ulcerative colitis, as well as enrollment completion in the Phase I trial of the antibody in healthy volunteers carried out in Australia.

/PRNewswire/ -- Earendil Labs，一家由人工智能驱动的生物技术公司，致力于推进下一代生物制剂的研发，今天宣布，在针对溃疡性结肠炎患者的IIa期临床试验中，首个患者已接受HXN-1001给药。HXN-1001是一种半衰期延长的抗TL1A抗体。此外，在澳大利亚进行的该抗体针对健康志愿者的I期临床试验已完成入组。

The Phase IIa trial is a randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HXN-1001 in ulcerative colitis patients..

IIa期试验是一项随机、安慰剂对照研究，旨在评估HXN-1001在溃疡性结肠炎患者中的安全性、耐受性、药代动力学和初步疗效。

HXN-1001 is a half-life extended, next generation anti-TL1A antibody with great potential for the treatment of patients with inflammatory bowel disease (IBD) including ulcerative colitis and Crohn's disease. In preclinical studies, HXN-1001 has demonstrated more potent efficacies in multiple in vitro assays and animal models than several benchmark products currently under clinical development.

HXN-1001 是一种半衰期延长、下一代抗 TL1A 抗体，在治疗炎症性肠病 (IBD) 患者方面具有巨大潜力，包括溃疡性结肠炎和克罗恩病。在临床前研究中，HXN-1001 在多种体外实验和动物模型中表现出比目前处于临床开发阶段的几种基准产品更强的效力。

Besides the extended in vivo half-life, HXN-1001 is formulated at a high protein concentration for subcutaneous injection. Taken together, HXN-1001 represents a potentially more efficacious and more convenient treatment option for IBD patients..

除了延长的体内半衰期，HXN-1001 还以高蛋白质浓度配方用于皮下注射。综合来看，HXN-1001 代表了一种对 IBD 患者可能更有效且更方便的治疗选择。

'In the Phase I study in healthy volunteers, HXN-1001 in single doses up to 1200 mg and multiple doses of 450 mg was well tolerated with a favorable safety profile. The antibody showed a half-life of about 8 weeks when dosed in the projected therapeutic dose range, with low incidence of anti-drug antibody response.' Zhenping Zhu, MD, PhD, President & Co-CEO of Earendil Labs, commented, 'We are working diligently to advance HXN-1001 clinical programs in a hope to bring a new and efficacious therapeutic option for IBD patients expeditiously.'.

“在健康志愿者的 I 期研究中，HXN-1001 单次剂量高达 1200 毫克、多次剂量为 450 毫克时，表现出良好的耐受性和有利的安全性特征。该抗体在预计的治疗剂量范围内给药时显示出约 8 周的半衰期，且抗药抗体反应的发生率较低。” Earendil Labs 总裁兼联席首席执行官朱振平博士评论道：“我们正在全力以赴推进 HXN-1001 的临床项目，希望能够迅速为炎症性肠病（IBD）患者带来一种全新且高效的治疗选择。”

Jian Peng, PhD, CEO of Earendil Labs, stated, 'The progression of HXN-1001 clinical development is a significant step on our pursuit of developing next-generation best-in-class biologic therapeutics in the treatment of patients suffering from IBD. We look forward to working closely with the clinical investigators and the IBD community to advance our development programs globally and to fully realize the great potential of HXN-1001.'.

健鹏博士，Earendil Labs首席执行官表示：“HXN-1001临床开发的进展是我们追求开发下一代一流生物治疗药物以治疗IBD患者的重要一步。我们期待与临床研究者和IBD社区紧密合作，推动我们的全球开发计划，并充分实现HXN-1001的巨大潜力。”

About Earendil L

关于Earendil L

abs

绝对值函数

Earen

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dil Labs is an

dil Labs是

AI-driven

人工智能驱动的

biotechnology company advancing next-generation biologics for patients with autoimmune diseases, cancer, and other areas of significant unmet medical need. By integrating artificial intelligence across the full R&D lifecycle, Earendil Labs and its affiliate Helixon Therapeutics have been building a scalable engine to systematically generate and advance high-quality therapeutic programs..

一家生物技术公司，致力于为自身免疫疾病、癌症和其他未满足重大医疗需求的患者推进下一代生物制剂。通过在研发全生命周期中整合人工智能，Earendil Labs及其附属机构Helixon Therapeutics一直在构建一个可扩展的引擎，以系统地生成和推进高质量的治疗项目。

The company's AI-native approach enables efficient creation, optimization, and progression of protein-based biologics with the potential to be first-in-class and best-in-class, translating computational innovation into real clinical and patient impact. Through a combination of internal pipeline development and strategic partnerships, Earendil Labs aims to deliver transformative medicines to patients worldwide..

公司的人工智能原生方法能够高效创造、优化和推进基于蛋白质的生物制剂，有潜力成为同类最佳，将计算创新转化为真正的临床和患者影响。通过内部管线开发与战略合作相结合，Earendil Labs旨在为全球患者提供变革性药物。

SOURCE Earendil Labs

来源：Earendil Labs

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