Potential Stroke Treatment Receives FDA Nod for Further Investigation

The Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for AB126 (Aruna Bio, Athens, Georgia), an unmodified neural-derived exosome to be studied as a potential treatment for acute ischemic stroke. According to a statement from Aruna Bio, AB126 shows evidence of anti-inflammatory and neuroprotective properties and has the innate ability to cross the blood brain barrier, according to results obtained from preclinical studies.

The IND clearance enables Aruna Bio to initiate a planned phase 1b/2b clinical trial to assess the safety, tolerability, and preliminary efficacy of AB126 as a treatment for people with acute ischemic stroke who have a poor prognosis after receiving a thrombectomy. In the clinical trial, participants will receive 3 intravenous injections of AB126 at a low, medium, and high dose. AB126 will be the first ever exosome to be investigated in human clinical trials for a neurologic indication.

“We look forward to building on the preclinical findings that showed AB126 may diminish neuro-inflammation, and potentially foster neuroprotection, and promote neuro-regeneration,” said Sean Savitz, MD, Primary Investigator, Professor of Neurology, and Director of the Institute for Stroke and Cerebrovascular Disease at UTHealth Houston.