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 Applauds Congressman McCormick for Introducing Federal Biotech Leadership Legislation

July 24, 2026
July 24, 2026, Atlanta, GA - Georgia Life Sciences applauds Congressman Rich McCormick (R-GA) for introducing the Biotechnology Diplomacy Leadership Act , legislation designed to strengthen America's leadership in biotechnology by establishing a senior biotechnology leadership position within the U.S. Department of State. As biotechnology continues to drive breakthroughs in healthcare, agriculture, advanced manufacturing, and national security, the United States must remain a global leader in innovation while strengthening strategic partnerships with allies around the world. The proposed legislation recognizes biotechnology as a critical component of U.S. economic competitiveness and foreign policy and would help ensure that the federal government is well positioned to advance these priorities internationally. The legislation also reflects recommendations from the National Security Commission on Emerging Biotechnology , which called for a more coordinated national approach to advancing biotechnology and protecting U.S. leadership in this strategically important sector. "Georgia is home to one of the nation's fastest-growing life sciences ecosystems, and policies that strengthen America's global biotechnology leadership directly benefit innovators, researchers, manufacturers, and patients," said Maria Thacker Goethe, President & CEO of Georgia Life Sciences. "We appreciate Congressman McCormick's leadership in recognizing biotechnology as both an economic engine and a strategic national priority." Georgia Life Sciences looks forward to working with policymakers at both the federal and state levels to advance policies that foster innovation, strengthen the U.S. bioeconomy, and ensure America remains the global leader in biotechnology.

Georgia Life Sciences Names Renee' Martin, Ph.D., Program Manager to Lead Flagship Educator Workforce Development Program

July 21, 2026
Georgia Life Sciences names Renee Martin, Ph.D., to lead its Teacher Training Initiative, advancing educator workforce development and Georgia's future life sciences talent pipeline.

Georgia Life Sciences Partnership Expands Plant Biotechnology Education for Agriscience Teachers Across Georgia

July 17, 2026
FOR IMMEDIATE RELEASE  July 16, 2026 ATLANTA, Ga . – Eighteen Georgia high school agriscience teachers recently participated in a hands-on plant tissue culture training at Cedar Shoals High School in Athens, equipping educators with biotechnology skills and classroom resources that will expand access to experiential STEM learning for students across the state. Hosted through a partnership led by Georgia Life Sciences (GLS), the workshop was facilitated by Julie Throne, Agriscience Teacher, FFA Advisor, and CTAE Department Chair at Cedar Shoals High School. Participants received practical instruction in plant tissue culture techniques using newly developed portable tissue culture kits generously donated by California-based Athena Ag. Plant tissue culture is a foundational biotechnology technique used in agriculture and plant science research to propagate plants under aseptic conditions. By incorporating these concepts into agriscience classrooms, educators can provide students with hands-on experiences that introduce biotechnology while building technical skills relevant to careers in agriculture and biotechnology. As part of the workshop, each participating teacher received two complete plant tissue culture kits to take back to their school, enabling students throughout Georgia to engage in laboratory-based biotechnology activities and explore emerging career pathways in the life sciences. "Providing educators with access to industry-relevant training and classroom resources is one of the most effective ways to inspire the next generation of Georgia's life sciences workforce," said Maria Thacker Goethe, President & CEO of Georgia Life Sciences. "Through partnerships like this, we're helping teachers bring real-world biotechnology into their classrooms while expanding opportunities for students to discover careers in one of Georgia's fastest-growing industries." The training is part of Georgia Life Sciences' broader Teacher Training Initiative, a statewide workforce development program that equips middle and high school educators with the knowledge, tools, and industry connections needed to deliver hands-on biotechnology instruction. Through strategic partnerships with industry, education, and nonprofit organizations, the initiative continues to strengthen Georgia's talent pipeline by connecting classroom learning with real-world workforce opportunities. Georgia Life Sciences extends its appreciation to Julie Throne for leading the training and to Athena for its generous donation of classroom kits, helping expand access to biotechnology education for educators and students across the state.
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