Pharma Focus Europe

Advantage Therapeutics Obtains Approvals for Clinical Trial of AD04™ in Treating Alzheimer's Disease in Poland, Bulgaria, and Slovakia

Wednesday, June 21, 2023

ADvantage Therapeutics, Inc. has announced that regulatory authorities in Poland, Bulgaria, and Slovakia have granted approval for its Clinical Trial Application (CTA) to conduct a clinical trial on AD04™, the company's lead candidate for the treatment of mild Alzheimer's disease (AD), in each respective country. The approved Phase 2b study will be a randomized, double-blind, placebo-controlled trial aimed at confirming proof-of-concept and evaluating the safety and efficacy of AD04™ in patients with mild AD.

Over the course of 12 months, the study will assess various outcomes including hippocampal volume as the primary objective and biomarker endpoint. The primary endpoint will be a composite score integrating ADAScog and ADCS-ADL, while other measured outcomes include hippocampal volume, CDR-sb, NPI, ADAScog13, ADCS-ADL, and patient Quality of Life-Alzheimer's disease.

Previous studies have shown that a 2mg dose of AD04™ in a control arm demonstrated significantly slower decline in cognitive and quality of life measures compared to other arms of the trial. The AD04™ control group also exhibited slower decline in MRI-measured hippocampal volume, a biomarker of AD progression. Preclinical studies have suggested that AD04™ reduces the number of inflammatory microglial cells in the hippocampus of mouse models, addressing pathological immunological events observed in the brains of Alzheimer's patients.

ADvantage Therapeutics recently received an Innovation Passport for AD04™ in the United Kingdom under the Innovative Licensing and Access Pathway (ILAP) for Alzheimer's treatment. This allows for collaboration with organizations such as the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and NHS England and NHS Improvement (NHSE&I). The ILAP incorporates innovation and patient needs according to the MHRA, with patients considered as key partners and their voices integrated at every stage of development.

Dr. Achim Schneeberger, the chief medical officer of ADvantage Therapeutics, expressed appreciation for the collaboration with regulatory agencies in Poland, Bulgaria, and Slovakia, and emphasized the potential of AD04™ to revolutionize the approach to Alzheimer's treatment. The company looks forward to evaluating the outcomes of the multinational study and providing updates on its progress and results.

ADvantage Therapeutics is committed to advancing the science of neurodegenerative diseases and developing innovative therapies that can significantly improve the lives of patients. Alzheimer's disease affects a large number of individuals worldwide and carries a significant socio-economic burden. Currently, there is a high unmet medical need for disease-modifying drugs in Alzheimer's treatment. AD04™ has the potential to offer a safe, effective, and affordable treatment that could help preserve patients' independence, dignity, and overall quality of life.

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