Alzinova AB (publ) announced positive top-line results from its phase 1b clinical trial of the vaccine candidate ALZ-101 in Alzheimer's disease. A first analysis of the study data shows that ALZ-101 has continued good tolerability, an acceptable safety profile and a high immune responder rate. Furthermore, the results show that patients treated with ALZ-101 responded with antibody levels that increased with the number of doses given.

A full analysis of the study data is expected to be completed in the first quarter of 2024. The positive results support continued clinical development of ALZ-101, and preparations for a planned phase 2 study are ongoing. The primary endpoint of the study is to evaluate the safety and tolerability of repeated doses of the vaccine candidate ALZ -101 in patients with early Alzheimer's disease.

The study also includes secondary and exploratory endpoints related to immune response and biomarkers. Exploratory efficacy data of the treatment's effect on biomarkers and cognition will be included in the full analysis of the study results, which is expected to be completed in The first quarter of 2024. The double-blind randomised phase 1b study included 26 patients with early Alzheimer's disease; The study, which is divided into two parts, is examining two different dose levels of ALZ-101, 125 and 250 ug, as well as placebo.

In part A of the study, 20 patients were treated with ALZ-101 vaccine and six patients with placebo. The top-line results are based on analysis after the first part of treatment when all patients received four doses over 20 weeks of treatment. Results from part A show good tolerability, an acceptable Safety profile and a high immune responders rate.

All 26 patients completed part A of the study. Antibody levels show that the patients administered with ALZ-101 responded favourably to treatment with antibody levels increasing with the number of doses given; One patient who entered the study with a history of ARIA-H (microbleeding) had a symptom-free increase in size. No patients developed ARIA-E (localised brain swelling).

All patients underwent magnetic resonance imaging to detect ARIA-E and ARIA-H. These types of side effects can occur with antibody treatment against the peptide Ab. ARIA-H may occur spontaneously in individuals with mild cognitive impairment or Alzheimer's disease. Clinical studies on Ab antibodies have previously shown an increased risk of both ARIA-E and ARia-H as a result of the treatments.

Alzinova is proceeding with the extension part (part B) of the study, where all patients are offered active treatment with ALZ-101 for a 20-week period. Patients are then followed during 48 weeks. Part B of the study will provide information on long-term safety and tolerability, the long-term immune response, as well as information on the effect on biomarkers and cognitive functions.

About ALZ-101 and Alzheimer's disease. 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 truly develop.