The new analyses build on previous reports in which Alzheimer's patients, treated with six doses of Alzinova's ALZ-101 for at least 12 months, demonstrated high and stable levels of plasma IgG antibodies directed against neurotoxic amyloid-beta (Aβ) oligomers. These oligomers are one of the key disease-driving mechanisms in Alzheimer's.
Analysis of cerebrospinal fluid (CSF) from a sample of patients now shows that IgG antibodies are also detectable in the central nervous system, with levels of at least 0,3% of those in the blood. This CSF to plasma ratio is comparable to levels observed with monoclonal antibody treatment, which, according to the company, underlines ALZ-101's potential to achieve therapeutic levels in the brain.
In a comment to BioStock, the CEO says Tord Labuda:
– The new results are an important piece of the puzzle that further strengthens our data package for ALZ-101. It not only clarifies the therapeutic value, but also significantly raises the commercial potential. I am convinced that this significantly increases our chances of securing a licensing agreement for the Phase II study. The timing is also optimal, as next week we will be attending BIO in Boston and will have the opportunity to present our progress to leading pharmaceutical companies and potential partners.
Convincing immunological response
Alzinova's Phase Ib trial of ALZ-101 was completed in the first quarter of 2025, with a total of 32 patients. The trial tested three dose levels (125, 250 and 400 µg) and a placebo group and demonstrated excellent safety, good tolerability and a strong immunological response in 95 percent of participants.
An extension phase, in which 23 patients were treated with 250 µg of ALZ-101 for 20 weeks followed by 48 weeks of follow-up, confirmed the study's primary and secondary endpoints. In addition, positive signals were observed in cognitive and functional parameters as well as stable levels of the biomarker neurofilament light chain (NFL), suggesting that ALZ-101 may slow disease progression.
In a previous comment Tord Labuda told BioStock:
- The results from the Phase Ib study with ALZ-101 are very encouraging. We have not only met our primary and secondary endpoints of 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.
Next steps: phase II and strategic collaborations
Alzinova is now preparing for the Phase II study, which will include a larger patient group to further evaluate the safety and efficacy of the vaccine. The company has completed the production of the active drug substance according to Good Manufacturing Practice (GMP) and plans to start production of the final vaccine formulation within three months. In parallel, Alzinova is working on regulatory applications, including an IND in the US and PRiME status in the EU.
To finance the development, Alzinova carried out a rights issue in April 2025, which raised SEK 30,3 million before issue costs. The issue was 85 percent subscribed with support from the board, management and existing shareholders.
The company has also intensified its efforts to establish strategic partnerships. In January 2025, Alzinova presented its Phase Ib results at JP Morgan Healthcare Conference in San Francisco, and the next major stop is the BIO conference in Boston, June 16–19, 2025, where the company hopes to make further contacts with potential investors and partners.
Future prospects for ALZ-101
With the new results confirming ALZ-101's ability to reach the central nervous system, together with previous positive data from the Phase Ib study, Alzinova is well positioned to take the next step in the development of the world's first vaccine against Alzheimer's disease. Further analyses of antibody dynamics in cerebrospinal fluid are ongoing, and the results are expected to provide even more insight into the therapeutic potential of the vaccine. Alzinova aims to initiate the Phase II study during second half of 2025.
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