Alzinova AB announced the primary analysis of study data from Alzinova's phase 1b clinical trial in Alzheimer's disease with the vaccine candidate ALZ-101. The analysis confirms the positive top-line results and that ALZ-101 was well tolerated and safe. Furthermore, the analysis confirms 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.

Full analysis of the dataset from the first part of this Phase 1b study (part A) confirms the favorable 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 g, had a higher response rate compared to 125 g, 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.