Annovis: FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Study

 Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced that the FDA has accepted an updated protocol for the pivotal Phase 3 AD 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.

https://www.globenewswire.com/news-release/2025/01/07/3005357/0/en/FDA-Accepts-Final-Protocol-for-Pivotal-Phase-3-Alzheimer-s-Disease-Study-Streamlining-Development-Pathway.html