Alzinova

“Alzinova has reached another important milestone now that all patients in the extension part of the study have received their last dose. We already have strong safety and tolerability data and positive antibody response results from part A. Part B will give us further valuable information about our promising vaccine candidate against Alzheimer's disease for the upcoming phase 2 study. We may obtain information from the extension part already in the autumn.” says Kristina Torfgård CEO of Alzinova AB.

Alzinova is developing a vaccine, ALZ-101, against Alzheimer's disease and is conducting a phase 1b clinical trial. The results from the first part of the study (part A) were reported earlier in 2024 and demonstrated a favourable safety and tolerability profile. Based on positive interim data from part A, the company decided in May 2023 to initiate an extension part, part B, of the ongoing clinical study. Part B of the study means that all patients treated in part A were offered treatment with additional doses of ALZ-101 over a 20-week period and the first patient in part B was dosed at the end of May 2023. Part B aims to provide information on long-term safety and tolerability, immune response, as well as possible signs of changes in biomarkers and cognitive functions. The information is important for the upcoming phase 2 clinical study for an optimised study design.

All patients have now received their fourth and final dose in Part B and will be followed for 48 weeks. Part B will end in early 2025. The company plans to conduct an analysis for the phase 2 study in autumn 2024, before part B is fully reported.

About ALZ-101 and Alzheimer's disease
Alzheimer's is a fatal disease that initially affects the brain and 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 memory loss, confusion and difficulty doing everyday things. The cause of the disease is not entirely clear, but the accumulation of toxic substances in the brain plays a role. There is currently no cure and although the first disease-modifying drugs have recently been approved in the US, 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.