Alzinova has developed ALZ-101, a therapeutic vaccine specifically designed to neutralize toxic amyloid-beta oligomers in the brain – a central factor in the development of Alzheimer's disease. The Phase Ib study, which was completed in Q1 2025, evaluated the vaccine's safety, tolerability and ability to induce an immune response in a total of 32 patients. The study included three dose levels (125, 250 and 400 µg) and a placebo group.
An extension phase was conducted in which 23 patients were treated with 250 µg of ALZ-101 for 20 weeks, followed by 48 weeks of follow-up. Results showed that the study met its primary and secondary objectives – with excellent safety, good tolerability and a strong immunological response in 95 percent of participants.
Of particular note are the positive signals in functional and cognitive parameters as well as the biomarker neurofilament light chain (NFL), an established indicator of nerve cell breakdown. Stable NFL levels in treated patients suggest that ALZ-101 can slow disease progression, further strengthening the company's confidence in the vaccine.
In a comment to BioStock, the CEO says Tord Labuda:
– The results from the Phase Ib study with ALZ-101 are very encouraging. We have not only met our primary and secondary endpoints regarding safety, tolerability and immunogenicity, but also seen promising data on cognitive parameters without signs of disease deterioration, which correlates with stable levels of neurofilament light (NFL), a biomarker of nerve damage. This strengthens our confidence in ALZ-101 and gives us a solid foundation to build on as we now prepare for Phase II.
Production and regulatory steps
While clinical development progressed, Alzinova completed the production of the active drug substance for ALZ-101 in collaboration with PolyPeptide Laboratories, according to Good Manufacturing Practice (GMP). This will allow production of the final vaccine formulation to begin in the summer of 2025.
To ensure a smooth transition to Phase II, Alzinova is now working on regulatory filings, including an IND (Investigational New Drug) in the US and PRiME status in the EU. The upcoming Phase II study will include a larger patient population and aims to further evaluate safety and efficacy.
In January 2025, Alzinova participated in JP Morgan Healthcare Conference in San Francisco. Here, the company presented the promising Phase Ib results to potential partners and investors. The participation is part of Alzinova's strategy to establish strategic collaborations to accelerate the development of ALZ-101 and maximize its commercial potential.
Strengthened financial position through rights issue
To finance preparations for Phase II, Alzinova completed a rights issue in April, raising SEK 30,3 million before issue costs. The issue was 85 percent subscribed and supported by commitments from board members, management and existing shareholders.
– We are now moving forward with the next step in development. Production work is complete, regulatory applications are being processed, and we have secured the capital required to get through the final preparations. The goal is to have everything in place – preclinical safety studies, regulatory work and scale-up – to be able to initiate the Phase II study in the second half of 2025. The issue proceeds give us the freedom of action we need to keep the pace up in the development of ALZ-101, a treatment we are determined to take all the way to patients, says CEO Tord Labuda
Read a previous interview here with Alzinova's CSO Anders Sandberg where he talks about ALZ-101's mechanism of action and what the observed biomarker data means for continued development.
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