The FDA approved Aruna Bio’s investigational new drug application for AB126, a neural-derived exosome, allowing it to enter a phase 1b/2a clinical trial for acute ischemic stroke treatment. AB126 can cross the blood-brain barrier and modulate the central nervous system’s inflammasome through anti-inflammatory and neuroprotective mechanisms, potentially treating various neurodegenerative disorders. The trial will test AB126’s safety, tolerability, and preliminary efficacy in acute ischemic stroke patients post-thrombectomy. Additionally, AB126 has shown promise in preclinical studies for ALS treatment, with treated mice demonstrating prolonged survival, reduced spinal inflammation, and lower serum neurofilament light chain levels, indicating its broader potential for chronic neurological conditions.
Reference: Ciccone I. FDA Clears Aruna Bio’s Exosome AB126 for Clinical Trials in Neurological Indication. Neurology Live. Updated January 16, 2024. Accessed January 22, 2024.
Link: https://www.neurologylive.com/view/fda-clears-aruna-bio-exosome-ab126-clinical-trials-neurological-indication
