ADvantage Therapeutics today announced groundbreaking results from a study on AD04™, a novel therapeutic candidate for Alzheimer's disease. Scientists from ADvantage presented the research poster "AD04™ - modifying Alzheimer’s disease by modulation of hippocampal lipid metabolism" at the Alzheimer’s Association International Conference,

Key Findings:

1. Pleiotropic Activity: Clinical and proteomics-based studies demonstrated that AD04™ exhibits durable and multifaceted effects, including both immediate symptomatic relief and long-term disease modification.
2. Safety Profile: AD04™ boasts an excellent safety profile in previous Phase 2 studies, notably not triggering ARIA-E/H, a common adverse event associated with other Alzheimer's treatments.
3. Mechanism of Action: Treatment with AD04™ significantly restored the expression of proteins involved in lipid metabolism in aged mice, aligning their levels with those of young mice. This restoration is believed to contribute to the therapeutic effects observed.
4. Lipid Metabolism: Key proteins in lipid metabolism, such as ACSL1, were found to be upregulated after AD04™ treatment. This suggests that the therapeutic benefits of AD04™ are closely tied to the modulation of hippocampal lipid metabolism.

Clinical Implications:

• Improved Cognitive Functions: The ability of AD04™ to modulate lipid metabolism and restore protein expression points to potential improvements in cognitive function and overall brain health in Alzheimer's patients.
• Novel Class of AD Drugs: AD04™ could represent the first of a new class of Alzheimer’s disease drugs, distinguished by its unique mechanism of action and safety profile.

"The significant and multifaceted benefits observed with AD04™ treatment mark a pivotal step forward in Alzheimer's research,” said Dr. Carmela R. Abraham, CSO of ADvantage. “We are optimistic that AD04™ may offer a new lifeline to patients and their families, providing both immediate symptomatic relief and modification of the disease progression."

The research has been well-received by the scientific community, with anticipation building around the upcoming clinical trials. ADvantage Therapeutics is committed to advancing this promising candidate through rigorous testing and regulatory review to bring a novel, effective, and safe treatment option to those affected by Alzheimer’s disease.

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 Alzheimer’s Disease, 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 Alzheimer’s Disease is enormous. AD devastates the lives of patients and their families. AD victims lose their memory and independence. Alzheimer’s Disease 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 the Wynwood neighborhood in Miami, ADvantage Therapeutics is developing therapies to treat neurodegenerative conditions with a central focus on Alzheimer’s Disease. The Company’s lead compound AD04™ is a subcutaneous injectable therapy that entered, in November 2023, 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.

About ADvantage Therapeutics GmbH

ADvantage Therapeutics GmbH, founded in 2021, is the Vienna BioCenter-based subsidiary of ADvantage Therapeutics, Inc., where the Company conducts early research and drug development.

Safe Harbor-Forward-Looking Statements

This press release may contain forward-looking statements, including statements of potential mode of action, potential clinical effect, potential safety, and ADvantage’s potential clinical development program and pipeline program. ADvantage is in the early stages of developing and testing its AD04™ compound and may not receive future regulatory approvals needed for marketing it as a drug. The described clinical effect of our lead compound AD04™ is primarily based on results of a Phase 2 study designed to evaluate a different compound. The described results need to be confirmed for proof of concept, might not be representative of larger scale clinical trials, and do not guarantee future clinical success. Any preclinical results presented here are interim. The mechanism of action of AD04™, as potentially determined in our future investigations, particularly in future clinical trials with patients with Alzheimer’s Disease, might differ from the one presented.

For more information, please contact:

Dr. Carmela R. Abraham, CSOADvantage Therapeutics, Inc.195 NW 40th StreetMiami, FL 33127Phone: +1-781-424-7090Email: Carmela@advantagetherapeutics.com 

Disclaimer: The views and opinions expressed herein do not reflect those of the Alzheimer's Association.