Alzinova has dosed the first patient in the extension part of its ongoing Phase Ib study of ALZ-101 to treat Alzheimer’s disease (AD).
The extension part of the study intends to provide information relating to the immune response, long-term safety, and tolerability of the vaccine candidate.
Patients who have already received their fourth vaccine dose in the Phase Ib study will now receive additional doses of ALZ-101 over a 16-week period in this part.
Alzinova CEO Kristina Torfgård said: “In addition, we have the opportunity to obtain information on the effect on biomarkers and cognitive functions.
“This is something that we see strengthens our position further and is valuable for future interactions with potential partners.”
The randomised, double-blind, placebo-controlled, first-in-human (FIH) Phase Ib study treated 20 patients with early AD using the ALZ-101 vaccine and six patients with a placebo over a 20-week period.
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The study is designed to investigate two different dose strengths of ALZ-101 and is conducted by Alzinova’s partner Clinical Research Services Turku (CRST Oy) in Finland.
CRST Oy has centres in Turku and Helsinki and is engaged in Alzheimer’s studies and research. The work on biomarkers is part of a research partnership with Gothenburg’s Sahlgrenska University Hospital.
ALZ-101 neutralises the toxic accumulations of the peptide amyloid-beta oligomers, which are said to be central to the onset and development of AD.