Aruna Bio Announces FDA Clearance of IND for Lead Program AB126, Enabling the First Exosome to Enter in Human Clinical Trials for a Neurological Indication

Aruna Bio

January 16, 2024·3 min read

-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. 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. 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.

“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

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