ADvantage Therapeutics Secures Approvals for Clinical Trial of AD04™ in Alzheimer’s Disease Treatment in Poland, Bulgaria, and Slovakia

MIAMI, June 20, 2023 (GLOBE NEWSWIRE) -- ADvantage Therapeutics, Inc. (“ADvantage” or “the Company”), a pioneer in developing therapies for neurodegenerative conditions with a focus on Alzheimer’s disease, today announced that regulatory authorities in Poland, Bulgaria, and Slovakia have approved its Clinical Trial Application (CTA) to conduct a clinical trial on its lead candidate, AD04™ for the treatment of mild Alzheimer’s disease (AD) in each respective country. 

The Phase 2b study authorized in these countries will be a randomized, double-blind, placebo-controlled trial aimed at confirming proof-of-concept and establishing the safety and efficacy of AD04™ in patients with mild AD.

The 12-month study will evaluate various outcomes including hippocampal volume as a primary objective and biomarker endpoint. The primary endpoint is to be composite score integrating ADAScog and ADCS-ADL Other measured outcomes include hippocampal volume, CDR-sb, the Neuropsychiatric Inventory (NPI), the Alzheimer’s disease Assessment scale – cognition 13-item scale (ADAScog13), the Alzheimer’s Disease Cooperative Study – Activities of Daily Living Standards (ADCS-ADL), and the patient Quality of Life-Alzheimer’s disease, all of which are reported either by study subjects or by their caregivers. The Company plans additional European study sites, incorporating additional countries such as France, Germany, and Austria.

In a previous study, a 2mg dose of AD04™ used in a control arm exhibited a statistically significantly slower decline in cognitive and quality of life measures compared to other arms of that trial. The AD04™ control group also showed slower decline in MRI-measured hippocampal volume as a biomarker of AD progression. Preclinical studies have indicated that AD04 decreased the number of inflammatory microglial cells in the hippocampus of mouse models. Inflammation and hyperproliferation of microglial cells are pathological immunological events observed in the brain of Alzheimer’s patients. 

Recently, the Company received an Innovation Passport for the treatment of AD under the Innovative Licensing and Access Pathway (ILAP) for AD04™ in the United Kingdom. This allows for close collaboration with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and NHS England and NHS Improvement (NHSE&I). In addition, patients are also considered key partners and the patient voice is integrated at every development stage. ILAP incorporates the concepts of innovation and patient need according to the MHRA.

Achim Schneeberger, M.D., chief medical officer of ADvantage Therapeutics, commented, “This represents an important milestone in the launch of our confirmatory trial. We are grateful to the regulatory agencies in Poland, Bulgaria and Slovakia for their collaboration, as we believe that AD04™ has the potential to completely change the approach to the treatment of Alzheimer’s disease. We look forward to evaluating the outcomes in this multi-national study specifically designed for AD04™ outcomes and providing updates on the course of the study, as well as its eventual results.”

ADvantage Therapeutics is dedicated to advancing the science of neurodegenerative diseases and committed to developing innovative therapies that can make a meaningful difference in the lives of patients. For more information on ADvantage Therapeutics, Inc., please visit

About AD04™
ADvantage Therapeutics is developing AD04™ as a novel immunotherapy for mild Alzheimer’s Disease. The compound has been used 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 significantly slower decline over other treatment groups in cognitive and quality life clinical measures. 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 address immunological mechanisms in the brain and at the periphery. The Company believes AD04™ may function as an immunomodulator, stimulating and/or regulating the immune system to reduce AD pathology.

About Alzheimer’s Disease
About forty-four million people worldwide suffer from Alzheimer’s Disease, and it 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. While the FDA provisionally approved an anti-amyloid-beta antibody, Aducanumab, in 2021, widespread coverage has not been granted, nor have European countries approved the product. The socio-economic burden of Alzheimer’s Disease is enormous. AD devastates the lives of patients and their families. They lose their memories and independence, and the loss of a loved relation leaves behind guilt, grief, and anger. 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
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 an injectable therapy in the process of entering into a confirmatory Phase 2b clinical trials in Europe to evaluate safety and efficacy of the product in mild Alzheimer’s Disease. 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 the aggregation of the proteins present once pathology is present. The Company is also exploring additional approaches to mitigating neurodegenerative disease, which it believes will eventually 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. ADvantage is developing therapies to treat neurodegenerative conditions like Alzheimer’s Disease (AD) and is currently preparing for clinical trials in Europe and in the U.S.

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 regulatory approval to conduct the contemplated Phase 2b trial. 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 regulatory approval or 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 ADvantage Therapeutics
195 NW 40th Street
Miami, FL 33127
Jeffrey Madden CEO
(305) 846-9027

David Buchsbaum CFO
(305) 846-9027

For Media:
Jules Abraham
JQA Partners, Inc.
(917) 885-7378

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