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 Joins National Coalition Urging Congressional Action on Key Innovation Policies

December 10, 2025
Georgia Life Sciences has joined 43 state and regional life sciences organizations in signing a national Council of State Bioscience Associations (CSBA) letter calling on Congress to take immediate action on three bipartisan policy priorities that are essential to sustaining U.S. leadership in biomedical innovation and supporting patients nationwide. With Congress back in session and several critical programs at risk of expiring, the letter urges congressional leaders to advance the following provisions without delay: 1. Reauthorize the Rare Pediatric Disease Priority Review Voucher (PPRV) Program The PPRV program has been instrumental in incentivizing the development of therapies for children with rare and life-threatening conditions. Its lapse threatens to slow or halt research that families across the country are counting on. 2. Extend the SBIR/STTR Programs The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs provide crucial early-stage capital for emerging biotech and medtech companies—many of them in Georgia. Without reauthorization, hundreds of innovative small businesses face uncertainty, jeopardizing new therapies, diagnostics, and technologies in the pipeline, 3. Advance PBM Transparency Reforms Greater transparency and accountability within pharmacy benefit manager (PBM) practices are needed to ensure that savings reach patients and employers. Reforming PBM operations is essential to strengthening access and affordability across the healthcare system. A Unified Message from the Life Sciences Community The sign-on letter reflects broad, bipartisan alignment across the national life sciences ecosystem: researchers, entrepreneurs, investors, patient advocates, and state associations all share a common message— these programs underpin America’s global competitiveness and are vital to patients who rely on continued scientific progress. Georgia Life Sciences has shared the letter with members of Georgia’s congressional delegation and will continue engaging with policymakers to emphasize the importance of swift action.

GLS Joins Georgia Partners in Calling for Federal PBM Reform

December 7, 2025
Georgia Life Sciences is proud to stand with patient advocates, providers, and employers across the state in urging Congress to take meaningful action on pharmacy benefit manager (PBM) reform. We recently signed on to a joint letter to Georgia’s Congressional Delegation stressing the urgent need for transparency, fair practices, and policies that ensure savings flow directly to patients.

GLS’ President and CEO, Maria Thacker Goethe in December's issue of Georgia Trend

December 4, 2025
Georgia Life Sciences’ CEO, Maria Thacker Goethe shares her perspective on the value of Georgia’s research universities in this month’s issue of Georgia Trend. “Georgia research institutions have felt a very significant impact from the federal rollbacks, specifically in NIH and NSF funding. Thacker Goethe’s message about the impact of research cuts is simple: Disruption shatters the foundational trust researchers have in grant continuity….” To read the full article, click here .
MORE POSTS