Annovis Bio receives FDA clearance to advance pivotal Phase 3 Alzheimer’s trials
Summary: Annovis Bio has received FDA clearance to begin pivotal Phase 3 studies for its Alzheimer’s drug, buntanetap. This follows a successful End-of-Phase 2 meeting on October 10, 2024, where the FDA acknowledged positive Phase 2/3 data.
The Phase 3 program will include two trials: a 6-month study to confirm symptomatic effects and an 18-month study to assess potential disease-modifying effects. The FDA raised no safety concerns regarding buntanetap, allowing development to proceed with a new crystal form of the drug.
Annovis plans to initiate the trials early next year, aiming for a New Drug Application submission based on the 6-month study results. The company focuses on addressing neurodegenerative diseases like Alzheimer’s and Parkinson’s.
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