“The results from the full analysis confirm that ALZ-101 is a promising vaccine candidate against Alzheimer's disease. The analysis confirms that the primary objective of safety and tolerability was met and also indicates positive results for the antibody response. We look forward to sharing our results with potential partners", says Alzinova’s CEO
Full analysis of the dataset from the first part of this Phase 1b study (part A) confirms the favourable safety and tolerability profile observed in all dose groups and a high frequency of immune response, and that patients treated with ALZ-101 responded with antibody levels that increased with the number of doses given. The analysis also shows that patients dosed with the highest dose of vaccine, 250 μg, had a higher response rate compared to 125 μg,
Exploratory endpoints regarding the effect of treatment on biomarkers and cognition were also analysed. The results show no clear change in biomarkers and exploratory endpoints for cognition, possibly due to the short duration of treatment. This is expected to be observed in the extension part of the study, which continues in 2024 with expected results in the first half of 2025.
Given the favourable safety and tolerability profile,
”The excellent safety profile opens up the possibility of optimising the treatment effect by maximising dose strengths”, she continues.
A scientific article describing the study results will be compiled for submission to a medical journal for publication. The results are also planned to be presented at upcoming international medical conferences.
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.
More about the phase 1b study
The primary objective of the study is to evaluate the safety and tolerability of repeated doses of the vaccine candidate ALZ-101 in patients with early Alzheimer's disease. The study also includes secondary and exploratory endpoints related to immune response and biomarkers.
The double-blind randomised phase 1b study included 26 patients with early Alzheimer's disease. The study, which is divided into two parts, is evaluating two different dose levels of ALZ-101, 125 and 250 μg, as well as placebo. In part A of the study, 20 patients were treated with ALZ-101 vaccine and six patients with placebo. The full analysis is based on previously communicated topline results from the first treatment arm when all patients received four doses over a 20-week period.
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