Annovis Bio Inc. announced on October 15, 2024, the successful outcome of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on October 10, 2024. The FDA granted clearance to proceed with pivotal Phase 3 studies for buntanetap in early Alzheimer's disease (AD) patients. This decision was based on the Company's Phase 2/3 clinical data, which showed symptomatic improvement.
Annovis and the FDA have aligned on a development path for buntanetap towards filing New Drug Applications (NDAs) for both short-term and long-term efficacy. The Phase 3 program will involve two trials: a 6-month study to confirm symptomatic effects and an 18-month study to assess potential disease-modifying effects. The Company believes that positive data from the initial 6-month period could support an NDA filing within one year of the study’s initiation.
The FDA also confirmed no concerns regarding buntanetap’s safety data, including liver enzymes, drug interactions, dose selection, pharmacokinetics, and population pharmacokinetics. The agency approved the use of a new crystal form of buntanetap for future development. This regulatory clarity and safety confirmation are crucial for advancing the drug.
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