Alzinova AB (“Alzinova” or the “Company”) announces that it has finalised the selection of seven clinical trial sites in the United States for ADVANCE, its global Phase 2a study evaluating the vaccine candidate ALZ-101 in patients with early Alzheimer’s disease. With the US site selection now finalised, Alzinova continues to advance preparations for participant recruitment, with the first participant targeted around the turn of 2026/2027.
The selected US sites have demonstrated experience in conducting high-quality Alzheimer’s disease clinical trials, including a strong track record in participant recruitment. The United States will form an important part of the global ADVANCE study, which is planned to be conducted in the United States, the European Union and the United Kingdom.
ALZ-101 has received FDA Investigational New Drug (IND) clearance, enabling the clinical study to proceed in the US, as well as Fast Track designation, which is intended to facilitate development and regulatory interactions for therapies addressing serious conditions with unmet medical need.
Recruitment of the first participant is expected around the turn of 2026/2027, subject to acceptance of the final protocol amendment and release of the clinical trial material following completion of the relevant quality controls.
Alzinova will provide further updates as the ADVANCE study progresses toward enrolment of the first participant.
For further information, please contact:
Tord Labuda, CEO
E-mail: IR@alzinova.com
About Alzinova AB
Alzinova AB is a Swedish biopharmaceutical company in clinical development specializing in the treatment of Alzheimer's disease, where the starting point is to attack toxic amyloid-beta oligomers. The lead candidate ALZ-101 is a therapeutic vaccine against Alzheimer's disease. Alzinova's patented AβCC peptide technology makes it possible to develop disease-modifying treatments that target the toxic amyloid-beta oligomers that are central to the onset and development of the disease with great accuracy. From a global perspective, Alzheimer's disease is one of the most common and devastating neurological diseases, with around 40 million affected today. Based on the same technology, the company is also developing the antibody ALZ-201, which is currently in preclinical development, and the goal is to further expand the pipeline. The company's Certified Adviser on Nasdaq First North Growth Market is Mangold Fondkommission AB. For more information about Alzinova, please visit: www.alzinova.com