Annovis Bio Inc. announced on January 7, 2025, that the FDA accepted an updated protocol for its pivotal Phase 3 Alzheimer's disease (AD) study, slated to begin in January 2025. This revised protocol integrates what were originally planned as two separate trials—a 6-month symptomatic study and an 18-month disease-modifying study—into a single 6/18-month trial. This consolidation aims to accelerate the development timeline.
The new design allows for a 6-month data readout focused on symptomatic effects, which could potentially support a New Drug Application (NDA) filing. The study will then seamlessly continue for an additional 12 months to assess the disease-modifying potential of buntanetap. This approach maintains scientific rigor while potentially expediting market access.
Maria Maccecchini, Ph.D., CEO of Annovis, stated that this consolidated protocol will accelerate the development timeline. It brings the company closer to delivering a novel treatment to patients in need. The FDA had previously granted clearance for Annovis to proceed with pivotal Phase 3 AD studies in October 2024, based on Phase 2/3 data showing cognitive improvement.
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