“Completing the treatment in the high-dose cohort marks an important milestone in the development of ALZ-101. We are encouraged by the progress made and remain optimistic about the potential of our vaccine candidate to offer a targeted, disease-modifying treatment for Alzheimer's. With the data from this study expected in early 2025, we are one step closer to advancing to the next phase of clinical trials, bringing us closer to addressing this devastating disease.” says Tord Labuda, CEO of Alzinova AB.

Alzinova is developing a vaccine, ALZ-101, against Alzheimer's disease and is conducting a phase 1b clinical trial. The first part (A1) of the study, demonstrated good safety and tolerability and a dose-dependent immune response were observed in patients. Based on these promising results, a high-dose part (A2) of the study was initiated, where all patients have now been dosed with all planned doses of ALZ-101. In total, patients have been treated on four occasions over a 16-week period, which is now followed by a four-week follow-up period ending in Q4 2024. Alzinova intends to present data from this part in the first quarter of 2025.

The main purpose of the high-dose cohort is to evaluate a higher dose of the vaccine candidate ALZ-101 ahead of a future phase 2 clinical study. By evaluating a higher dose, the company can both strengthen the knowledge of the vaccine candidate and optimize the conditions and study design for the phase 2 study.

About ALZ-101
Alzinova's approach of developing vaccine and antibody treatments that specifically target the toxic accumulations of amyloid-beta in the form of oligomers in the brain, has several advantages over other approaches. Other treatments target larger accumulations of amyloid-beta, known as plaques in the brain, which are believed to contain both toxic and harmless proteins. Alzinova has developed a method that could specifically target the brain's toxic amyloid-beta oligomers, one of the underlying causes of Alzheimer's disease. Vaccination with ALZ-101 involves the body generating its own antibodies, specific to toxic accumulations of amyloid-beta oligomers in the brain. These toxic substances are expected to be neutralised, thus protecting the brain's synapses from damage, which could slow or prevent the development of Alzheimer's disease. The treatment method is also expected to have a lower risk of side effects such as brain oedema. The company therefore believes that it is likely to be more successful than other broader approaches to Alzheimer's disease.

For more information, please contact:
Tord Labuda, CEO
Tel: +46 (0)70 838 23 23
E-mail: tord.labuda@alzinova.com

About Alzinova
Alzinova AB is a Swedish clinical-stage biopharma company specializing in the treatment of Alzheimer’s disease targeting toxic amyloid beta oligomers. The lead candidate, ALZ-101, is being developed as a therapeutic vaccine for the treatment of Alzheimer's. Alzinova’s proprietary AβCC peptide™ technology enables the development of disease-modifying treatments that target the toxic amyloid beta oligomers involved in the onset and progression of the disease with high precision. Alzheimer’s is one of the most common and devastating neurological diseases globally, with of the order of 40 million people afflicted today. In addition, the antibody ALZ-201 is in preclinical development, and the ambition is to expand the pipeline further. 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