Axion Neuroscience, A leading clinical-stage biotech company, has published completed phase II clinical trial results where Alzheimer’s Vaccine AADvac1 was found to be most effective on the subgroup of patients with confirmed Alzheimer’s disease. The trial has shown positive results and has met its endpoints, the company said.
ADAMANT, a 24-month randomised, placebo-controlled, trial, was conducted to assess the safety and efficacy of the AADvac1 vaccine in patients with mild Alzheimer’s. The company said that the primary objective was to evaluate the safety and tolerability of long-term AADvac1 treatment, the secondary objectives included the evaluation of immunogenicity and vaccine efficacy in slowing cognitive and functional decline.
The results showed that in the subgroup of patients with confirmed Alzheimer’s disease biomarker profile, according to the study, AADvac1 slowed the clinical decline by 27 per cent as measured by CDR-SB and functional decline by 30 per cent, as measured by ADCS-MCI-ADL. In further comparison to the placebo, the vaccine considerably reduced the NFL blood levels by 62 per cent (p value=0.010).
The abstract of the paper also reported that the vaccine induced high levels of IgG antibodies and that no significant effects were found in cognitive and functional tests on the whole study sample.
Michal Fresser, CEO of Axon Neuroscience, said in his presentation said; “Our Phase II trial successfully demonstrated the strengths of our lead asset AADvac1, a tau vaccine on track to prevent and treat Alzheimer’s disease,” and added, “The results confirm the disease-modifying effect of AADvac1”.
The results of its completed Phase II study were published in the journal Nature Aging. The abstract of the report stated: “Alzheimer’s disease (AD) pathology is partly characterised by accumulation of aberrant forms of tau protein. Here, we report the results of ADAMANT, a 24-month double-blinded, parallel-arm, randomised phase 2 multi-centre placebo-controlled trial of AADvac1.”