Aruna Bio, Inc., a leader in the development of neural exosomes for the treatment of neurodegenerative diseases, announced the company has been awarded a Small Business Innovation Research (SBIR) Phase II grant by the National Institutes of Health in the amount of $4.5 million to support research and development leading up to an Investigational New Drug (IND) application for the use of neural stem cell-derived extracellular vesicles (“neural exosomes”) for the treatment of acute ischemic stroke.

“We are very pleased and honored to be recipients of this grant which is a direct reflection of the years of work by our Chief Scientific Officer and Founder, Dr. Steven Stice, and the employees of Aruna Bio. This second grant allows us to continue to progress our neural exosome, AB126, to an IND filing which will position us to begin our first human studies,” said Dr. Mark A. Sirgo, Chief Executive Officer. “While this grant provides important financial resources to progress AB126 toward the clinic for acute ischemic stroke, we continue to position our internal resources on development programs using our neural exosome platform for the treatment of neurodegenerative diseases including amyotrophic lateral sclerosis, or ALS.”

Acute ischemic stroke occurs in nearly 800,000 people annually and is a leading cause of long-term disability in the U.S. There is currently a high unmet need for new therapies, as 90% of all ischemic stroke patients do not meet the inclusion criteria for use of current treatment interventions and suffer poor functional outcomes resulting in death or severe long-term impairment. In multiple pre-clinical models, the neural exosome AB126 demonstrated improved structural and functional outcomes and represents a potential novel approach to the treatment of stroke.

In particular, the $4.5 million grant, which was awarded on September 18, 2019, will support studies that enable IND filing in 2021 by conducting definitive nonclinical pharmacology and toxicology studies. The grant will be available in installments over time and funds the full scope of work supporting the IND filing. Receipt of the full grant amount is subject to NIH award terms and conditions outlined in the grant.

Research reported in this press release was supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number R44NS103596. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.