The DSMB consists of an independent expert group that continuously review the safety data accumulated during the progress of the study, which is standard for all drug development. The company has previously communicated several positive reviews from the DSMB during the phase 1b study. The recent review relates to both the extension part (B part) and the high-dose part (A2 part) of the phase 1b study, which aims to evaluate a higher dose of the vaccine candidate ALZ-101 for the upcoming phase 2 study.
Kristina Torfgård, CEO of
"We are pleased with the continued positive response from the independent expert group and that there are no obstacles from a safety perspective to conduct these parts of the study. I am very satisfied that we continue to see good safety and tolerability in the study and that the study can proceed as planned. We look forward to data from part A2 and also data from part B in the autumn of 2024 where the information will give us a more comprehensive picture of the vaccine candidate's immune response, which is strategically important for the phase 2 study."
About Alzheimer's disease and the vaccine candidate ALZ-101
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.
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