Aruna Bio Announces FDA Clearance of IND for Lead Program AB126, Enabling the First Exosome to Enter in Human Clinical Trials for a Neurological Indication

January 16, 2024 08:00 ET| Source:  Aruna Bio

BOSTON and ATHENS, Ga., Jan. 16, 2024 (GLOBE NEWSWIRE) — Aruna Bio, Inc., a pioneer in the development of neural exosome-based therapeutics for the treatment of neurodegenerative diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of lead program, AB126. This decision paves the way for the Phase 1b/2a clinical trial in acute ischemic stroke, which is expected to initiate in the first half of 2024. AB126 is an unmodified neural-derived exosome with an innate ability to traverse the blood brain barrier and shows evidence of anti-inflammatory and neuroprotective properties.

“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,” said Steven Stice, Ph.D., Co-Founder and Chief Scientific Officer of Aruna. “Further, maintaining cells under controlled conditions is a key aspect of exosome manufacturing and we look forward to leveraging our in-house GMP manufacturing expertise to support clinical advancement. 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.”

Aruna’s proprietary in-house GMP production facility allows for the manufacture of clinical grade batches under conditions that enable optimal and scalable consistency. Additionally, the unique purification techniques allow precise control over critical quality attributes. The establishment of protocols for analytical methods and well-characterized assays ensure therapeutic consistency.

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

About the Phase 1b/2a Clinical Trial

The planned dose-ascending clinical trial will evaluate the safety, tolerability, and preliminary efficacy of AB126 in patients with an acute ischemic stroke that have undergone a thrombectomy. Patients will receive three intravenous injection treatments of AB126 at a low, medium, and high dose. Patients with a poor prognosis post thrombectomy will be enrolled in the trial.

About Acute Ischemic Stroke

Acute ischemic stroke, caused by a clot blocking blood flow to the brain, is a leading cause of long-term disability and mortality worldwide. Current treatments, such as clot-busting drugs and mechanical thrombectomy, are effective but have strict time constraints for administration, often leaving a significant number of patients ineligible. Additionally, these treatments do not address the complex cascade of cellular and molecular events triggered by ischemia. Therefore, there is a critical need for innovative therapies that can extend the treatment window, mitigate neuronal damage, and enhance recovery, thereby improving outcomes for a broader range of stroke patients.

About Aruna Bio

Aruna Bio is a leader in the development of neural exosomes for the treatment of neurodegenerative diseases. The company is utilizing its proprietary neural exosome platform and manufacturing capability to develop a pipeline of neural exosome-based therapeutics able to cross the blood brain barrier and enhance the body’s anti-inflammatory, self-repair and protective mechanisms to treat a range of neurodegenerative disorders where significant unmet medical need exists today. Additionally, the company’s neural exosome platform can be combined with therapeutics, such as small molecules, siRNAs and proteins, to cross the blood brain barrier and to the site of disease.

Investor Contact:

Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.com

LINK: https://www.globenewswire.com/en/news-release/2024/01/16/2809846/0/en/Aruna-Bio-Announces-FDA-Clearance-of-IND-for-Lead-Program-AB126-Enabling-the-First-Exosome-to-Enter-in-Human-Clinical-Trials-for-a-Neurological-Indication.html

Georgia Life Sciences Designates Paulding County as Newest BioReady® Silver Community

January 20, 2026
January 20, 2026. Paulding County has been designated a BioReady Silver Community by Georgia Life Sciences, the state’s leading life sciences membership organization. The BioReady designation recognizes communities that demonstrate strong zoning practices, infrastructure capacity, and readiness to support biotechnology and life sciences development. “We are proud to recognize Paulding County as our newest BioReady Silver community,” said Maria Thacker-Goethe, President and CEO of Georgia Life Sciences. “Paulding County’s proactive planning, growing workforce, and access to regional healthcare and transportation infrastructure position it well to support life sciences manufacturing and commercialization. Through the BioReady program, we champion communities that are intentionally preparing to compete for industry investment and job growth.” Paulding County’s designation reflects its commitment to thoughtful land-use planning, scalable infrastructure, and business-friendly development policies that support life sciences and advanced manufacturing uses. Located in the northwest Atlanta metro region, the county offers access to a strong labor pool, major transportation corridors, and regional healthcare systems, making it an attractive option for biotechnology, medical device, diagnostics, and related life sciences companies seeking room to grow. “Georgia BioReady designation validates Paulding County’s readiness to support bioscience investment and strengthens our position as a growing hub for advanced industries,” said Alex Almodovar, President & CEO, Paulding County Economic Development Inc. & Industrial Building Authority The BioReady rating system evaluates communities across three tiers—Bronze, Silver, and Gold—based on their readiness to attract and support life sciences facilities. Through these ratings, Georgia Life Sciences helps municipalities better showcase biotech-appropriate sites, strengthen infrastructure planning, and clearly identify life sciences-friendly locations. This approach enables communities like Paulding County to compete more effectively for private investment and high-quality job creation. Georgia Life Sciences advances innovation, strengthens the workforce pipeline, and grows Georgia’s life sciences economy through the BioReady Community program, modeled after MassBio’s nationally recognized rating system, which assesses a community’s readiness to host life sciences facilities based on zoning practices and infrastructure capacity. About Georgia Life Sciences Georgia Life Sciences, founded in 1989, is a non-profit, membership-based organization that promotes the interests and growth of the life sciences industry. It is the state’s largest and most influential life sciences advocacy and business leadership organization working to improve access to innovative discoveries that have lifesaving impact. The association connects business, academia, government, and other allied entities involved in the application of life sciences products to fuel growth and collaboration through policy development, community programs, national industry initiatives, and a portfolio of educational and networking events. Learn more at galifesciences.org.

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