– Extremely significant effects on neurodegeneration have been shown for brain proteins in plasma – neurofilament light chain, CSF – tau and p-tau, and diffusion tensor imaging;
– The vaccine has an excellent antibody response;
– AADvac1 has been confirmed to be safe and well tolerated
AXON Neuroscience SE (“Axon”), an industry-leading, clinical-stage biotech company that is at the forefront of treating and preventing Alzheimer’s disease, today delivered positive results at the AAT-AD / PD 2020 conference announced its Phase II trial for AADvac1. AADvac1 is the first tau vaccine to treat and prevent Alzheimer’s disease.
The Phase II ADAMANT clinical trial was designed as a 24-month, randomized, placebo-controlled, double-blind, multicentre, parallel-group study to assess the safety and efficacy of AADvac1 in patients with mild Alzheimer’s disease.
The primary goal was safety, and the secondary goals were to assess immunogenicity, efficacy based on clinical results, and important biomarkers for neurodegeneration. Axon recruited 196 patients in eight European countries. 163 patients completed the study, with a low dropout rate of 14.5% for the treatment group and 20.3% for the placebo group.
Phase II of the ADAMANT study – results
Compared to the placebo group (p-value = 0.004), AADvac1 showed a disease-modifying effect with a significant reduction in the neurodegenerative process by 58%, for which purpose the neurofilament light chain (“NfL”) was measured. The NfL released in the blood and cerebrospinal fluid (“CSF”) is a dynamic biomarker that indicates the extent of progressive neurodegeneration in patients with Alzheimer’s disease and other neurological diseases.
Phase II results suggest that AADvac1 can prevent further neuronal damage in patients and maintain a level similar to that commonly seen in healthy elderly people.
The effects of the vaccine were most evident from the clinical results that could be seen in younger patients. Compared to the placebo group, AADvac1 slowed the clinical decline measured by CDR-SB by 42% (p-value = 0.062) in patients with early Alzheimer’s disease and showed a 31% reduced MMSE value and a 26% reduction ADCS-MCI-ADL value.
For the group of younger patients in the early stages, the cognitive and functional effect was associated with a significantly reduced rate of neuronal NfL accumulation in the blood of 73% compared to the placebo group (p-value = 0.033). This corresponds to twice the effect observed for the study population as a whole. In addition, a significantly reduced atrophy of the brain could be determined for each individual brain area affected by Alzheimer’s disease. The reduction in brain volume declined the most in the cerebral cortex. Compared to the placebo group (p-value = 0.021), there was a decrease of 47%. This combination of clinical and biomarker-based results illustrates the disease-modifying effects of AADvac1 therapy.
Phase II of the ADAMANT trial successfully reached its primary endpoint, with AADvac1 proving safe and well tolerated. In addition, the robust quantity and exceptional affinity of induced antibodies in more than 80% of patients confirmed AADvac1’s outstanding tau antibody response.
The therapeutic effect of the vaccine was further demonstrated by a decrease in the CSF biomarkers (total tau, phosphotau-T181 and phosphotau-T217), which reflected a reduction in tau pathology in treated patients.
In addition to the other biomarkers, AADvac1 significantly reduced white brain degeneration, as measured by diffusion tensor imaging (DTI). This observation reveals the inhibitory effect of AADvac1-induced antibodies on the pathological spread of tau and confirms the mechanism of action of the serum antibodies.
Michal Fresser, CEO of Axon Neuroscience, presented the results and said: “Despite the very challenging times we are currently experiencing worldwide, we must not forget that Alzheimer’s is also an impending global pandemic. There is a new case of every four seconds Dementia in the World, but now that we have the evidence of AADvac1’s disease-modifying potential in our hands, we should focus on getting the treatment to the 35 million people who have Alzheimer’s worldwide as soon as possible. ”
Clinical Dementia Rating – Sum of Boxes, Mini Mental State Examination and Activities of Daily Living are widely recognized measurement methods for clinical outcomes to assess cognitive and functional degradation in Alzheimer’s. Magnetic resonance imaging and diffusion tensor imaging, on the other hand, are modalities that track the degree of brain atrophy and damage that are strongly associated with disease progression.
Over the past two decades, Axon has shown in numerous publications that tau pathology is the main driver of Alzheimer’s disease. Axon has developed the AADvac1 vaccine, which can stop the progression of tau pathology and thus alleviate the symptoms of sufferers. In addition, the occurrence of the disease in potential victims can be prevented. It is currently the most clinically advanced tau therapy for the treatment and prevention of Alzheimer’s.
The vaccine has several unique therapeutic properties. It differs from other tau-based research in that it targets the formation of tau proteins and the spread of the types of tau proteins that have already formed. AADvac1-induced antibodies distinguish between normal and pathological tau, so that only the latter are attacked. This not only makes the treatment of axon more effective, but also safer.
About Axon Neuroscience
Axon Neuroscience is an industry-leading, clinical-stage biotech company and a pioneer in the treatment and prevention of Alzheimer’s. The company was founded in 1999 and now has the world’s largest team dedicated exclusively to tau research related to Alzheimer’s, with over 60 scientists and 15 scientific directors.
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Original content from: AXON Neuroscience SE, transmitted by news aktuell
Original message: https://www.presseportal.de/pm/126155/4564245