Aruna Bio has announced plans to initiate a Phase I/II clinical trial of AB126 for the treatment of acute ischaemic stroke in the first half of 2024.

The decision comes after the US Food and Drug Administration (FDA) cleared the company’s investigational new drug (IND) application of its lead programme AB126.

The development marks the first IND for the company’s platform.

AB126 is an unmodified exosome derived from proprietary neural stem cells, and demonstrates potential anti-inflammatory and neuroprotective effects.

The upcoming dose-ascending trial will assess the tolerability, safety, and preliminary efficacy of AB126 in patients who have suffered an acute ischaemic stroke and undergone a thrombectomy.

The trial will involve patients with a poor prognosis post-thrombectomy who will receive three intravenous injections of AB126 at varying doses.

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By GlobalData

Aruna Bio co-founder and chief scientific officer Steven Stice said: “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. 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 CNS treatments.”

Acute ischaemic stroke, a condition resulting from a blood clot obstructing the blood flow to the brain, is a major cause of disability and death globally.

UTHealth Houston Institute for Stroke and Cerebrovascular Disease director Sean Savitz said: “We look forward to building on the preclinical findings that showed AB126 may diminish neuro-inflammation, and potentially foster neuroprotection, and promote neuro-regeneration.”