Annovis Bio announced that it has completed the final patient study visit in its Phase 3 trial of buntanetap (also known as ANVS401 and Posiphen) for early Parkinson’s disease.
The trial, A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD, enrolled 450 patients with early Parkinson’s and randomized them to 10 or 20 mg of buntanetap or placebo for six months. Primary outcome measures were MDS-Unified Parkinson’s Disease Rating Scale Part II+III and safety and tolerability of the once-daily oral treatment.
Buntanetap is unique in that it targets multiple neurotoxic proteins—amyloid β, tau, alpha-synuclein, and TDP43—implicated in a range of neurological disorders including Alzheimer’s disease, dementia with Lewy bodies, and Parkinson’s. It works by blocking the translation of these proteins and restoring them to normal levels, which improves neuronal function.
Annovis recently completed a Phase 2 trial of buntanetap that demonstrated its ability to lower TDP43 blood levels in patients with Parkinson’s and is recruiting for a Phase 2/3 trial in mild to moderate Alzheimer’s disease. Results from the Phase 3 trial in early Parkinson’s are expected in January 2024.
