On 13 February, Annovis Bio, a clinical-stage drug platform company developing novel treatments for neurodegenerative diseases such as Alzheimer's disease (AD), announced an update for its Phase II clinical trial investigating its lead compound ANVS401 in AD. The study is being conducted in collaboration with the Alzheimer Disease Cooperative Study (ADCS) group. The trial is a randomised, double-blind and placebo-controlled Phase II study evaluating the efficacy and safety of ANVS401 in people with early AD. ANVS401 is a small orally administrated brain penetrant inhibitor of neurotoxic proteins. Previous Phase I studies reported that ANVS401 was well tolerated.
The Data Safety Monitoring Board overseeing the Phase II study has reviewed the data (safety, enrolment, participant status, demographic and vital signs of patients) and recommended the continuation of the trial without modification. The analysis of the data did not show any adverse effects in the enrolled research participants. The trial is designed to recruit 24 research participants at 6 US sites and has already enrolled 11 research participants. Interim data from the study are expected in Q4 2020. ANVS401 is also being developed to treat Parkinson’s disease, Lewy Body dementia and other Lewy Body diseases.