Alzinova AB (publ) announced that all patients participating in the extension part (part B) of the phase 1b study with the vaccine candidate ALZ-101 against Alzheimer's disease, have received their last dose of ALZ-101. Part B of the study aims to investigate safety and tolerability during a longer period of treatment with ALZ-101. Alzinova is developing a vaccine, ALZ-101, against Alzheimer's disease and is conducting a phase 1b clinical trial.

The results from the first part of the study (part A) were reported earlier in 2024 and demonstrated a favourable safety and tolerability profile. Based on positive interim data from part A, the company decided in May 2023 to initiate an extension part, part B, of the ongoing clinical study. Part B of the study means that all patients treated in part A were offered treatment with additional doses of ALZ-101 over a 20-week period and the first patient in part B was dosed at the end of May 2023.

Part B aims to provide information on long-term safety and tolerability, immune response, as well as possible signs of changes in biomarkers and cognitive functions. The information is important for the upcoming phase 2 clinical study for an optimised study design. All patients have now received their fourth and final dose in Part B and will be followed for 48 weeks.

Part B will end in early 2025. The company plans to conduct an analysis for the phase 2 study in autumn 2024, before part B is fully reported.