First patient recruited into Alzinova's phase 1b clinical study with the oligomer-specific ALZ-101 vaccine against Alzheimer's disease
- Category: Vaccines
- Published on Friday, 29 October 2021 17:43
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STOCKHOLM, Sweden I October 29, 2021 I Alzinova AB (publ) (FN STO: ALZ), a Swedish biopharma company developing treatments of Alzheimer's disease by specifically targeting neurotoxic amyloid-beta oligomers, today announces that the first patient has been recruited into its phase 1b clinical study with ALZ-101 in Finland.
"It is very satisfying that ALZ-101 has now entered clinical testing in an area with such a huge unmet medical need. We are looking forward to continuing the development of this potential disease-modifying treatment with the long-term goal to treat and prevent the onset and progression of this devastating disease," says Kristina Torfgård, CEO of Alzinova AB.
More about the study
The Phase 1b clinical study with ALZ-101 in patients with early Alzheimer's disease is a placebo-controlled, double blind, randomised First In Human (FIH) trial. It will evaluate the vaccine candidate's tolerability and safety.
It will also study the immunological response to the vaccine after multiple doses, as well as a number of biomarkers associated with Alzheimer's disease. In total, 26 patients will be included in the study. The study participants will receive four doses of either ALZ-101 or placebo. The study investigates two different dose strengths of ALZ-101 during a treatment period of 20 weeks. Topline data for the study is anticipated in the second half of 2023.
The clinical trial is being carried out in Finland by Alzinova's partner, Clinical Research Services Turku (CRST), who have extensive experience in Alzheimer's studies. The analysis of biomarkers will be made through a research collaboration with Sahlgrenska University Hospital in Gothenburg.
About Alzinova AB