Swedish biopharmaceutical company Alzinova AB (Nasdaq First North Growth Market:ALZ) on Thursday announced the completion of the final analysis of its Phase 1b clinical study for vaccine candidate ALZ-101, targeting early Alzheimer's disease.

The study successfully met its primary and secondary objectives, demonstrating safety, tolerability and immunogenicity. Exploratory endpoints indicated a stable disease progression among participants.

Results of the Phase 1b trial exceeded expectations, showing trends suggestive of a clinically meaningful treatment effect, as stated by Alzinova's CEO. The study also indicated positive effects on a key neurodegenerative biomarker. ALZ-101 exhibited a favourable safety profile with minimal side effects.

Patients receiving ALZ-101 developed comparable levels of anti-oligomeric IgG antibodies across different doses. Booster doses administered during the extension period resulted in a rapid production of IgG antibodies, which remained measurable for 52 weeks post-administration. T-cell analyses supported these findings, indicating a strong humoral immune response.

Exploratory data from the study suggested that most patients treated with ALZ-101 did not experience clinical deterioration over the study's duration, averaging 100 to 140 weeks. The vaccine did not induce neuroinflammation or alter plaque pathology, affirming its safety and specific targeting of toxic amyloid-beta oligomers. A trend towards lower neurofilament light values was observed in patients receiving ALZ-101, potentially indicating a slowing of neurodegeneration.

Other biomarkers showed responses to ALZ-101, but changes were small and not sustained. Alzinova believes that the results suggest ALZ-101's potential to slow disease progression and provide a targeted treatment. The company anticipates proceeding to a larger Phase 2 study to further validate these promising findings.