Annovis Bio announces FDA acceptance of protocol for Phase 3 AD study

Annovis Bio (ANVS) announced that the FDA has accepted an updated protocol for the pivotal Phase 3 Alzheimer’s Disease study, which is slated to begin in January 2025. In October 2024, the FDA granted clearance for Annovis to proceed with the pivotal Phase 3 AD studies based on its Phase 2/3 data demonstrating cognitive improvement in early-stage AD patients. The original protocol design proposed two separate trials: a 6-month symptomatic study and an 18-month disease-modifying study. Under the revised protocol, these studies are now integrated into a single 6/18-month trial, which will include a 6-month data readout focused on symptomatic effects, followed by an additional 12-month assessment to evaluate the disease-modifying potential of buntanetap.