Alzinova AB, a Swedish clinical-stage biopharmaceutical, is advancing a dual approach to alzheimer’s disease by initiating the global phase II start-up of its therapeutic vaccine ALZ-101 and developing a blood-based diagnostic based on its Aβ42CC technology.
The phase II program follows a completed phase Ib study that the company claims showed favorable safety and tolerability, generated strong, long-lasting Aβ-specific immune responses and produced exploratory analyses indicating stabilization of cognition and relevant biomarkers over two years versus historical controls.
ALZ-101 has also received FDA Investigational New Drug clearance and Fast Track designation, the company claims. With Worldwide Clinical Trials, the company has completed the Phase II study kick-off and begun operational start-up, and plans to enroll approximately 120 participants with early Alzheimer’s disease, with the first participant expected around the turn of 2026/2027.
Alzinova is expanding its Aβ42CC technology into diagnostics in collaboration with Amsterdam UMC and has signed a letter of intent with Fujirebio to explore development and global commercialization of a blood-based test.
To fund the next stage, Alzinova has launched a rights issue of approximately USD 5.5 million intended to finance phase II initiation, CMC activities and working capital.
