ADvantage Therapeutics Awarded $2.5 milion NIH SBIR Grant to Advance Alzheimer’s Drug Candidate AD04® Toward the Clinic
MIAMI, Sept. 26, 2025 (GLOBE NEWSWIRE) -- ADvantage Therapeutics, Inc., a biotechnology company developing novel therapies for neurodegenerative diseases, today announced it has been awarded a $2.5 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute on Aging of the National Institutes of Health (NIH). This non-dilutive grant will further important research supporting AD04®, the company’s phase 2 Alzheimer’s candidate.
“This award strongly validates our approach to Alzheimer’s disease,” said Dr. Carmela Abraham, Chief Science Officer. “With NIH support, we are one step closer to helping patients suffering from this devastating condition.”
The SBIR program is one of the most competitive NIH funding initiatives, designed to support small businesses advancing cutting-edge science with high commercial potential.
“The NIH’s support underscores the strength of our science and alongside our UK ILAP designation (conditional market approval after phase 2) and EU CTAs validates AD04® as a global program. This award positions us to accelerate regulatory momentum and attract the strategic partners required for broad patient access,” said Jeffrey Madden, Co-Founder and CEO.
This news follows the recent publication of encouraging AD04® results in The Journal of Prevention of Alzheimer’s Disease (JPAD) https://pubmed.ncbi.nlm.nih.gov/40953123/. The publication highlighted encouraging results from AD04’s earlier Phase 2 trial. A follow-up independent statistical analysis confirmed that the positive effects seen in patients were reliable and not due to chance. These findings suggest that AD04 produced a treatment effect that compared favorably to monoclonal Alzheimer’s therapies already on the market, while being easier to take, safer, and more affordable.
About AD04™
ADvantage Therapeutics is developing AD04™ as a new class of therapeutic for mild Alzheimer’s disease that exhibits durable multifaceted effects, including both immediate symptomatic relief and long-term disease-modification. The compound has been used extensively as an adjuvant in human and animal vaccination programs. In a previous trial, AD04™ serving as a control against another compound appeared to demonstrate statistically significant slower decline in cognitive and quality of life clinical measures compared to other treatment groups. AD04™ also showed slower decline in hippocampal volume as a biomarker.
The Company believes that rather than being limited to a specific aspect of AD pathology, such as amyloid beta or tau, AD04™ may restore expression of genes in lipid metabolism, improve phagocytosis and reduce inflammation. Through multiple mechanisms AD04™ functions as an immunomodulator, stimulating and/or regulating the immune system to reduce AD pathology.
About Alzheimer’s Disease
About fifty million people worldwide suffer from AD, which is the sixth leading cause of death in industrialized countries. In 2019, the World Health Organization estimated the total worldwide cost of dementia at $1.3 trillion and expects this cost to rise to $2 trillion by 2030. The socio-economic burden of AD is enormous. AD devastates the lives of patients and their families. AD victims lose their memory and independence. AD is a high unmet medical need as there are currently no disease-modifying drugs approved worldwide. The availability of a safe, effective, affordable drug would transform the life of an AD patient from accepting a debilitating disease to the retention of personality, independence, and dignity.
About ADvantage Therapeutics, Inc.
Headquartered in Miami, ADvantage Therapeutics is developing therapies to treat neurodegenerative conditions with a central focus on AD. The Company’s lead compound AD04™ is a subcutaneous injectable therapy that is ready to enter, confirmatory Phase 2b clinical trials in Europe, to evaluate its safety and efficacy in early AD patients. The Company believes that AD04™ may function as an immunomodulator, stimulating and regulating the immune system to reduce AD pathology, rather than limiting therapy to attack the misfolded proteins, beta amyloid and tau. The Company is exploring additional approaches to mitigating neurodegenerative disease, among them increasing the levels of Klotho, a life and health extending protein which will have an overall impact on longevity.
Funding Acknowledgment
Research reported in this press release is supported by the National Institute on Aging (NIA) of the National Institutes of Health under Award Number 1R44AG091827-01. The content is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health.
For more information, please visit: www.advantagetherapeutics.com
Media Contact:
Jeffrey Madden
Chief Executive Officer
195 NW 40th Street
Miami, FL 33127
Jeff@advantagetherapeutics.com
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