“From these new analyses, we see promising results that indicate that there are patients who already after 16 weeks of treatment with our vaccine candidate respond positively to biomarkers related to Alzheimer’s disease. This feels fantastic and we are now looking forward to the upcoming evaluation of longer treatment time and higher dose with ALZ-101. The result is also important in our partner dialogues and preparations for the phase 2 study.”, says Alzinova’s CEO Kristina Torfgård.

Since January 2024, when Alzinova announced positive results from the primary analysis of the phase 1b study with the vaccine candidate ALZ-101 against Alzheimer’s, further analyses of the study data have been conducted. In the analyses, the company has examined exploratory endpoints, such as biomarkers related to the disease, which are important as they may indicate a potential effect of the drug. The results of the new analyses indicate a positive change in biomarkers in the cerebrospinal fluid of the patients who showed high antibody levels, so-called immune responses, during part A of the study. The change has been identified already after 16 weeks of treatment with four doses of ALZ-101. The company plans to continue to follow up and analyse the biomarkers after treatment with a higher dosein part A2 and for a longer period of timein part B of the study.

”The results from Alzinova’s analysis of biomarkers in the phase 1b study are very promising. The fact that we can observe an effect on biomarkers in the spinal fluid suggests that the vaccine has a therapeutic effect. I believe in Alzinova’s development of a drug that targets the toxic accumulations of amyloid known as oligomers, and I look forward to the results of upcoming clinical studies on the vaccine candidate.”, says Henrik Zetterberg, professor of neurochemistry at the University of Gothenburg and University College London and scientific advisor to Alzinova.

The results are planned to be presented at upcoming international medical conferences.

About ALZ-101 and Alzheimer’s disease
Alzheimer’s is a deadly disease that affects the brain and initially leads to problems with memory, thinking and behaviour. It is the most common form of dementia, and it mostly affects older people. Symptoms develop gradually and include forgetfulness, confusion and difficulty doing everyday things. There is currently no cure and although the first disease-modifying drugs have recently been approved in several countries, there is still a very long way to go to truly treat and prevent the development of Alzheimer’s disease.

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.