-Phase 1b/2a clinical trial in acute ischemic stroke expected to initiate in 1H 2024- -Marks the first IND for Aruna’s platform with plans to expand AB126, an unmodified exosome derived from proprietary neural stem cells, to other neurological indications including amyotrophic lateral sclerosis- -Proprietary in-house GMP production capabilities enable scalable, reproducible production of clinical-grade exosomes with high purity and uniformity; analytical methods and well-characterized assays established to ensure therapeutic consistency- BOSTON and ATHENS, Ga., Jan.

-预计将于2024年上半年启动的急性缺血性卒中1b/2a期临床试验-标志着阿鲁纳平台的第一个IND，计划将AB126（一种源自专有神经干细胞的未修饰外泌体）扩展到其他神经系统适应症，包括肌萎缩性侧索硬化症-专有的内部GMP生产能力可扩展，具有高纯度和均匀性的临床级外泌体的可重复生产；为确保治疗一致性而建立的分析方法和特征明确的分析方法-波士顿和雅典，佐治亚州，1月。

16, 2024 (GLOBE NEWSWIRE) -- Aruna Bio, Inc., a pioneer in the development of neural exosome-based therapeutics for the treatment of neurodegenerative diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of lead program, AB126.

2024年16月16日（环球通讯社）--Aruna Bio，Inc.是开发用于治疗神经退行性疾病的基于神经外泌体的疗法的先驱，今天宣布美国食品和药物管理局（FDA）已经批准了铅计划AB126的研究性新药（IND）应用。

This decision paves the way for the Phase 1b/2a clinical trial in acute ischemic stroke, which is expected to initiate in the first half of 2024. AB126 is an unmodified neural-derived exosome with an innate ability to traverse the blood brain barrier and shows evidence of anti-inflammatory and neuroprotective properties.

这一决定为急性缺血性卒中的1b/2a期临床试验铺平了道路，预计将于2024年上半年开始。AB126是一种未修饰的神经衍生外泌体，具有穿越血脑屏障的先天能力，并显示出抗炎和神经保护特性的证据。

“We are thrilled with this validation from the FDA, which not only positions AB126 as the first exosome to enter human clinical trials for a neurological indication, but underscores the therapeutic feasibility of our platform,” said Steven Stice, Ph.D., Co-Founder and Chief Scientific Officer of Aruna.

Aruna联合创始人兼首席科学官Steven Stice博士说：“我们对FDA的这一验证感到兴奋，它不仅将AB126定位为第一个进入人类神经系统临床试验的外泌体，而且强调了我们平台的治疗可行性。”。

“Further, maintaining cells under controlled conditions is a key aspect of exosome manufacturing and we look forward to leveraging our in-house GMP manufacturing expertise to support clinical advancement. Simultaneously, we are expanding AB126’s applications across other indications, including.

“此外，将细胞维持在受控条件下是外泌体制造的一个关键方面，我们期待着利用我们内部的GMP制造专业知识来支持临床进步。同时，我们正在扩展AB126在其他适应症中的应用，包括。