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Alzinova announces phase 1b data

The company has 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 top-line results and that ALZ-101 was well tolerated and safe, states the company. 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, it states.

“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 Kristina Torfgård.

The extension part of the study

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 favorable safety and tolerability profile, Alzinova has applied for an addition to the study where a higher dose will be evaluated. The extension will be done as an open-label part of the study and includes six patients who will be treated with 400 μg over a 16-week period with four treatment sessions. The patients will then be followed up for an additional 4 weeks. This is not expected to affect the timetable for the planned phase 2 study.

Photo of Kristina Torfgård: Alzinova/GU Ventures News