New positive safety review for Alzinova's phase 1b study
Alzinova AB (publ) (ticker: ALZ), announces today that a new external safety review of the company's phase 1b clinical trial has been conducted - with a positive assessment to continue the study as planned. The review was conducted by an independent expert group, the Data Safety Monitoring Board ("DSMB"), which continuously reviews the study. Based on all patients enrolled in the extension part of the study and the first patient enrolled in the high-dose part, the DSMB recommends continuing the study as planned.
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 Alzinova, comments:
"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.
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.