A second planned interim analysis has been conducted of the ongoing clinical phase 1b study with the company’s vaccine candidate ALZ-101 against Alzheimer’s disease.
The analysis shows positive data with continued good safety and tolerability as well as a clear immunological response, that is, that specific antibodies have been formed, states the company. Based on this positive second interim analysis, the company has decided to conduct an extension of the study.
”The fact that we are now obtaining good results in the second interim analysis is very positive and shows that we are well on the way to developing a vaccine that can make a big difference in the fight against Alzheimer’s. Based on these positive data, we now look forward to conducting the extension part of the study, which means that all patients are offered active treatment with ALZ-101. We of course look forward to top-line data in the second half of 2023 that will give us a more comprehensive picture of the immune response of the vaccine candidate in all patients,” says CEO Kristina Torfgård.
About the study
Alzinova is developing a vaccine, ALZ-101, against Alzheimer’s disease in a phase 1b clinical trial that accurately neutralizes the toxic accumulations of the peptide amyloid-beta, known as oligomers, which are central to the onset and progression of the disease. The phase 1b clinical study 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 the 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. As previously communicated, top-line data for the study is expected in the second half of 2023.
The study is conducted in Finland by Alzinova’s partner, Clinical Research Services Turku-CRST Oy, 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.
Analysis of 26 patients administered with ALZ-101 or placebo showed that those treated with ALZ-101 responded to treatment with antibody levels increasing with the number of doses given. The analysis also shows continued good safety and tolerability.
The planned extension means that all patients who have received their fourth vaccine dose will be offered treatment with two doses of ALZ-101 during an additional 16-week period. The extension part of the study aims to provide information on long-term safety and tolerability, immune response, as well as information on effects on biomarkers and cognitive functions.