FDA clears Aruna Bio’s IND for AB126 to enter clinical trials
Betsy Goodfellow | January 17, 2024 | News story | Research and Development | Aruna Bio, FDA, IND, Neurology, clinical trials
Aruna Bio has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its lead programme, AB126, meaning it can enter a phase 1b/2a clinical trial for acute ischemic stroke.
The trial is expected to begin 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,” according to the company’s press release.
Steven Stice PhD, co-founder and chief scientific officer of Aruna Bio, commented: “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. 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 amyotrophic lateral sclerosis, and exploring the broader potential of our neural exosome platform in overcoming existing challenges in central nervous system (CNS) treatments.”
Sean Savits MD, primary investigator and professor of Neurology, director of the Institute for Stroke and Cerebrovascular Disease at UTHealth Houston, US, added: “We look forward to building on the preclinical findings that showed AB126 may diminish neuro-inflammation, and potentially foster neuroprotection, and promote neuro-regeneration.”
Betsy Goodfellow
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