AD04™ Offers Hope for Alzheimer’s Patients: Clinical Trial Gains Approval in Europe for Revolutionary Treatment.

ADvantage Therapeutics, Inc. continues its pioneering approach in treating Alzheimer’s disease as authorities in Poland, Bulgaria, and Slovakia recently gave the green light to an exciting clinical trial featuring the company’s leading candidate, AD04™.The novel therapy is being targeted to help mild AD patients, and is believed to bring much needed relief to many sufferers around the world. This renewed optimism is bringing ADvantage members and the medical community hope for a much better tomorrow.

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.

This is your opportunity to make a difference! Join us in our 12-month study and evaluate various objectives with hippocampal volume as our primary endpoint. Measure outcomes such as the composite score incorporating ADAScog and ADCS-ADL, CDR-sb, NPI, ADAScog13, ADCS-ADL and the patient Quality of Life-Alzheimer’s disease, all of which allow us to report subject and caregiver findings. Take the opportunity to join us and participate in this study, for which we currently have plans to extend our reach to other European countries, such as France, Germany and Austria.

AD04™ is an encouraging new treatment for Alzheimer’s disease. In a prior study, it showed statistically significant benefits for both cognitive and quality of life measures. MRI scans of the brains of participants also revealed that participants who used AD04™ experienced a slower decline in hippocampal volume, a key indicator of Alzheimer’s progression. Preclinical studies on mice have further suggested that AD04™ can decrease the number of inflammatory microglial cells in the hippocampus, providing evidence of potential immunological benefits in the fight against Alzheimer’s.

Recently, the Company has been awarded an Innovation Passport for a groundbreaking new treatment of AD04™ in the United Kingdom as part of the Innovative Licensing and Access Pathway (ILAP). Through ILAP, the Company is collaborating closely with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and NHS England and NHS Improvement (NHSE&I). The focus here is on infusing innovation and patient need through this initiative, with the patient voice driving development at every stage.

ADvantage Therapeutics is thrilled to announce a major milestone in the launch of its confirmatory trial of AD04™ for the treatment of Alzheimer’s disease – the successful collaboration with regulatory agencies in Poland, Bulgaria and Slovakia! Chief Medical Officer, Achim Schneeberger M.D., is confident that this breakthrough could entirely revolutionize the approach to treating Alzheimer’s and is eagerly awaiting the outcomes of this multi-national study. The results of this endeavor, as well as its progression, will be shared as they come in.

About AD04™

ADvantage Therapeutics is pioneering a groundbreaking new immunotherapy: AD04™. With promising results in animal and human vaccine-related trials, this novel treatment holds potential to become the first serious option for mild Alzheimer’s Disease.

AD04™ was found to reduce cognitive decline and enhance quality of life measures when tested against another compound, and even slowed down the loss of hippocampal volume – a key biomarker in the condition. With this glimmer of hope, ADvantage Therapeutics is taking steps towards transforming the future of Alzheimer’s treatment.

AD04™ has the potential to be a revolutionary immunomodulator in the fight against Alzheimer’s disease. By addressing immunological mechanisms both in the brain and in the body, AD04™ aims to reduce AD pathology and provide a comprehensive approach to this complex and devastating condition. We are optimistic that this innovative therapy could be an important step in the fight against Alzheimer’s disease.

About Alzheimer’s Disease

Alzheimer’s Disease is a devastating condition, with an estimated 44 million people worldwide suffering from it and representing the sixth leading cause of death in developed countries. The WHO has estimated its yearly worldwide economic cost to be close to $1.3 trillion and expects it to reach the $2 trillion-mark by 2030. Even though a provisional FDA approval of Aducanumab, an anti-amyloid-beta antibody, was granted this year, European countries have yet to approve it and it has yet to be made widely available.

All of this makes Alzheimer’s Disease a significant unmet medical need, without any disease-modifying drugs approved to help retain an AD patient’s independence, personality and dignity. We can only hope that a safe and effective solution with affordable costs will be found soon, and step by step allow those suffering from Alzheimer’s Disease to reclaim their memory and true selves.

About ADvantage Therapeutics

ADvantage Therapeutics — located in Miami’s vibrant Wynwood district — is on a mission to develop revolutionary therapies to combat neurodegenerative conditions with a specific focus on Alzheimer’s disease. The Company’s leading product, AD04™, is an injectable therapy that is now entering into a confirmatory Phase 2b clinical trial in Europe to measure safety and efficacy in mild Alzheimer’s Disease patients.

Scientists believe AD04™ has the potential to regulate and stimulate the immune system to battle Alzheimer’s pathology, rather than treating protein aggregation after it has already occurred. Moreover, ADvantage is looking to explore even more approaches that could positively impact longevity for those suffering from neurodegenerative diseases.

About ADvantage Therapeutics GmbH

ADvantage Therapeutics GmbH was founded in 2021 as the Vienna BioCenter-based subsidiary of ADvantage Therapeutics, Inc. and is dedicated to finding innovative treatments for neurodegenerative diseases like Alzheimer’s. With cutting-edge research and drug development underway, the company is primed to launch clinical trials both in the U.S. and Europe, moving us closer to a cure for this devastating condition.

Safe Harbor-Forward-Looking Statements

ADvantage is on the cusp of an exciting step forward with the AD04™ compound; the potential mode of action, along with the potential clinical effect and safety, could drive forward a potentially expansive clinical development program and pipeline program. This will be tested and refined in a proposed Phase 2b trial; one that could lead to robust clinical results including, but not limited to, proof of concept.

In addition, current studies provide an initial indication of the efficacy of the lead compound AD04™ and further progress is eagerly anticipated. With further trials, the mechanisms of action of AD04™ as determined in clinical trials with Alzheimer’s Disease patients could be a major advancement in the medical world.

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