ALZ-101
GOTHENBURG, Sweden, Sept. 21, 2026 (GLOBE NEWSWIRE) — As World Alzheimer’s Day highlights the continued unmet need in Alzheimer’s disease, Swedish clinical-stage biopharmaceutical company Alzinova AB (Nasdaq First North: ALZ) is advancing on two fronts: initiating the global Phase II start-up of its therapeutic vaccine ALZ-101 while advancing a blood-based diagnostic program based on the same proprietary technology.
The Phase II program follows a completed Phase Ib study in which ALZ-101 showed a favorable safety and tolerability profile and generated strong, long-lasting Aβ-specific immune responses. Exploratory analyses also showed stabilization of cognition and relevant biomarkers over two years, supporting the potential for slower disease progression versus historical controls. ALZ-101 has also received FDA Investigational New Drug (IND) clearance and Fast Track designation.
Together with Worldwide Clinical Trials, Alzinova has completed the Phase II study kick-off and commenced the operational start-up phase. Approximately 120 participants with early Alzheimer’s disease are planned for enrollment, with the first participant expected around the turn of 2026/2027.
At the same time, Alzinova is expanding the potential applications of its proprietary Aβ42CC technology into diagnostics. In collaboration with Amsterdam UMC, the company is developing a blood-based test to validate and build on findings from the Phase Ib study. Separately, Alzinova has signed a Letter of Intent with Fujirebio to explore the test’s potential development and global commercialization.
“Alzheimer’s research is entering a period where earlier diagnosis and new treatment approaches increasingly need to move forward together. Our technology allows us to address both. With ALZ-101 entering Phase II start-up and our diagnostic program advancing, we are entering an important new stage of development,” comments Tord Labuda, CEO of Alzinova.
To fund the next stage, Alzinova has launched a rights issue of approximately USD 5.5 million. The net proceeds are intended primarily to fund the initiation of the Phase II clinical study, related Chemistry, Manufacturing and Controls (CMC) activities and working capital.
For further information, please contact:
Tord Labuda, CEO
E-mail: [email protected]
www.alzinova.com
About Alzinova AB
Alzinova AB is a Swedish clinical-stage biopharmaceutical company developing treatments for Alzheimer’s disease, with a focus on toxic amyloid-beta oligomers. Its lead candidate, ALZ-101, is a therapeutic vaccine. Alzinova’s patented AβCC peptide technology enables the development of disease-modifying treatments targeting toxic amyloid-beta oligomers central to disease onset and progression.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5ddb99c4-f530-49cb-9d51-60276f6765cb
