Aruna Bio Secures U.S. Patent for Neural Exosome Therapeutic Delivery

Aruna Bio, Inc., a pioneering company in neural exosome-based therapeutics aimed at treating neurodegenerative diseases, has announced that the U.S. Patent and Trademark Office has granted them Patent No. 11,993,787. This patent pertains to their lead program, AB126, which is an exosome derived from proprietary neural stem cells. AB126 has shown an ability to cross the blood-brain barrier and exhibits anti-inflammatory and neuroprotective properties. This patent is expected to extend the protection for AB126, as well as products for gene therapy using AB16, until at least 2038.

Dr. Steven Stice, Co-Founder and Chief Scientific Officer of Aruna Bio, expressed satisfaction with the new patent, emphasizing that it strengthens their extensive patent portfolio and supports their unique exosome platform for treating neurological and other conditions. He confirmed that the company is on schedule to initiate a Phase 1b/2a clinical trial for AB126 in treating acute ischemic stroke in the latter half of 2024. This patent will also enable the company to further investigate the potential of neural exosomes and expand their application to other conditions such as amyotrophic lateral sclerosis (ALS). Dr. Stice highlighted that the patent secures Aruna Bio's leading position in developing unmodified neural exosomes for therapeutic uses, including future gene therapies delivered through these exosomes.

The upcoming Phase 1b/2a clinical trial is designed to be a dose-ascending study that will assess the safety, tolerability, and preliminary effectiveness of AB126 in patients who have experienced an acute ischemic stroke and have undergone a thrombectomy. The trial will administer three intravenous injections of AB126 at varying doses—low, medium, and high. Patients with poor prognoses following a thrombectomy will be selected to participate in the trial.

Aruna Bio is making significant strides in the treatment of central nervous system (CNS) disorders through its innovative neural exosome platform. The company's lead product, AB126, has demonstrated various beneficial activities, including the ability to penetrate the blood-brain barrier, offer neuroprotection, and reduce neuro-inflammation. These properties suggest a wide range of potential applications across different neurological diseases, including ALS, Alzheimer's disease, and stroke.

The company's internal cGMP (current Good Manufacturing Practice) facility is instrumental in supporting the development and clinical testing of their pipeline products. Aruna Bio's strategic approach includes using their exosome platform for drug delivery and exploring combination therapies, thereby laying the groundwork to address unmet needs in CNS treatment.

Aruna Bio's advancements in neural exosome-based therapeutics highlight their commitment to tackling severe neurological conditions. By leveraging their proprietary technologies and pursuing robust clinical trials, they aim to bring effective treatments to patients suffering from debilitating neurodegenerative diseases.