So I can't find any earlier research on animals that says what this is trying to fix. So go ask your competent? doctor what this will be doing for recovery.
FDA clears investigational new drug application for novel stroke therapy
Key Takeaways:
- AB126 is an unmodified neural-derived exosome developed to treat acute ischemic stroke.
- A planned phase 1b/2a clinical trial is expected to start in the first half of 2024.
The FDA has cleared an investigational new drug application for an unmodified neural-derived exosome to treat those with acute ischemic stroke, according to its manufacturer.
In a press release, Aruna Bio Inc. said the FDA’s decision will allow its lead program, AB126, which can cross the blood-brain barrier, to be examined in a pending phase 1b/2a study that is expected to begin during the first half of this year.
The dose-ascending clinical trial will evaluate safety, tolerability and preliminary efficacy of AB126 in those with acute ischemic stroke who have previously undergone a thrombectomy. All participants in the trial — including those with a poor post-thrombectomy prognosis — will receive three IV treatments of AB126 at low, medium and high doses, per the release.
“We are thrilled with this validation from the FDA,” Steven Stice, PhD, co-founder and chief scientific officer of Aruna, said in the release. “Further, maintaining cells under controlled conditions is a key aspect of exosome manufacturing, and we look forward to leveraging our in-house manufacturing expertise to support clinical advancement.”
Aruna added that it plans to expand AB126’s applications to include amyotrophic lateral sclerosis as well as to explore broader potential of its neural exosome platform to address ongoing challenges in treating central nervous system conditions.
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