FDA clears investigational new drug application for novel stroke therapy

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

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