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.
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Read More on ANVS:
- Annovis Bio Advances Alzheimer’s and Parkinson’s Drug Trials
- Annovis Bio Appoints William Fricker as Interim CFO
- Annovis sees cash runway for Phase 3 preparatory studies, entering AD study
- Annovis Bio reports Q3 EPS (97c), consensus (39c)
- Annovis Bio appoints Peterson as Senior Clinical Scientist
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