Policy & Regulation
AXON Neuroscience SE announces results of Phase II AADvac1 trial
10 September 2019 -

AXON Neuroscience SE, a clinical stage biotech company involved in the treatment and prevention of Alzheimer's disease, announced yesterday the results of the Phase II trial for AADvac1, its first-in-class vaccine to decrease the progression of Alzheimer's Disease.

The trial was designed as a randomised, double-blinded, placebo- controlled trial in mild Alzheimer's Disease. The aim was safety, with secondary objectives to assess immunogenicity, efficacy on clinical results and key biomarkers.

The company studied the product on 196 patients in eight European countries over 24 months, in order to prove the concept of disease modifying effect of the vaccine and to inform the design of future confirmatory studies.

For the primary endpoint, the ADAMANT trial indicated that AADvac1 has proven to be safe and well tolerated, with no difference in the incidence and nature of adverse events between the treatment and placebo groups. No other safety signals emerged from any other safety or medical assessments. This confirms the overall benign safety profile of AADvac1, demonstrated in prior clinical trials.

Based on the extensive learnings and positive data generated by the Phase II ADAMANT trial, Axon is moving ahead with plans for the upcoming clinical development.

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