Alzinova

In December 2022, the Company announced that all patients had been recruited and received a first dose and that a first interim analysis had been carried out which showed good safety and tolerability and indications of an immunological response. All participants in the study have now received their fourth and final dose, they will be followed for 48 weeks and Alzinova expects to be able to present topline data from the study in the second half of 2023. In addition, a second interim analysis of all included patients will be conducted in the spring.

CEO Kristina Torfgård comments:
"It is very exciting that the study is now entering a new phase. So far, the execution of the study has gone as planned and with the last dose administered, we have reached another important milestone in our phase 1b study. We will now follow these patients and already this spring we are looking forward to interim data. Thereafter, topline data later in 2023 will give us a more comprehensive picture of the vaccine candidate's safety and immune response. We have high hopes for positive results so that we can accelerate the development of a vaccine in the fight against Alzheimer's."

The phase 1b clinical trial of ALZ-101 in patients with early Alzheimer's disease is a placebo-controlled, randomized, double-blind First In Human (FIH) study. The study includes 26 patients where study participants have received four doses of either ALZ-101 or placebo. The study examines two different dose strengths of ALZ-101 over a 20-week treatment period. In the study, 20 of the patients are treated with the ALZ-101 vaccine and 6 patients with placebo.

The study is conducted in Finland by Alzinova's partner, Clinical Research Services Turku Oy (CRST), which has extensive experience in Alzheimer's studies and research with centers in Turku and Helsinki. The work on the biomarkers is part of a research collaboration with Sahlgrenska University Hospital in Gothenburg.

About ALZ-101
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 a therapeutic vaccine that specifically targets the toxic accumulations of amyloid-beta in the form of oligomers in the brain has several advantages over other approaches. Other players are developing treatments that target larger accumulations of amyloid-beta, known as plaques in the brain, which are thought to contain both toxic and harmless protein. It has been shown that this is unlikely to be sufficiently effective and can result in serious side effects. In contrast, Alzinova has managed to identify a method that could specifically target the toxic protein in the brain, 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 neutralized, protecting the brain's synapses from damage and potentially preventing the development of Alzheimer's disease. The treatment method is also expected to have a lower risk of side effects such as bleeding and edema. The company therefore believes that it is likely to be more successful than other broader approaches to Alzheimer's disease.