On 9 September, Axon Neuroscience announced positive top line results from their Phase II trial of AADVac1, showing good safety profiles and substantial reduction in neurodegeneration biomarkers in participants treated with AADVac1. AADVac1 is a tau vaccine that functions by priming the immune system to attack and clear damaging tau proteins that accumulate during the development of Alzheimer’s disease (AD) and other neurodegenerative disorders. Unlike other immunotherapy approaches, AADVac1 specifically targets disease-associated, misfolded tau proteins. A previous randomised, placebo-controlled Phase I clinical trial of AADVac1 showed a favourable safety profile and excellent immunogenicity in participants who received repeated doses of AADVac1. The ADAMANT Phase II trial aimed verify these safety results in a larger participant population, whilst also assessing efficacy in terms of clinical and biomarker outcomes.
ADAMANT was designed as a randomised, double-blind, placebo-controlled trial, enrolling 196 participants with mild AD from 8 centres across Europe. Over a period of 24 months, participants received a total of 11 doses of AADVac1 or a placebo control. Endpoint analysis confirmed the results of the previous Phase I trial, showing an excellent safety profile for AADVac1. AADVac1 was also able to induce a robust immune response, with anti-Tau antibodies detected in 98.2% of participants receiving the vaccine. Significant results from biomarker tests were also reported: participants who received AADVac1 showed slower increases in neurofilament light chain (a marker of neurodegeneration) compared to those who received the placebo control. Positive signals from cognitive endpoints were reported in younger ADAMANT participants, although it should be noted that Axon did not provide details of the statistical measures used here. Based on these positive results, Axon Neuroscience hope to continue the development of AADVac1 in further clinical trials.
http://www.axon-neuroscience.eu/docs/press_release_Axon_announces_positive_result_9-9-2019.pdf