ADvantage Therapeutics Announces Breakthrough Findings in Alzheimer's Disease Treatment: AD04TM shows immediate symptomatic and disease-modifying properties
July 30 2024 - 11:04AM
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:
- 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.
- 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.
- 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.
- 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.