Annovis Bio, Inc. (ANVS), a clinical-stage biotechnology company, announced on Tuesday that the FDA has accepted its updated protocol for the pivotal Phase 3 Alzheimer's Disease or AD study, set to begin in January 2025.
The new protocol consolidates the original plan for two separate trials into a single 6/18-month study.
The first 6 months will focus on symptomatic effects, while the subsequent 12-month period will assess the disease-modifying potential of buntanetap.
This streamlined approach accelerates the timeline for development while ensuring scientific rigor. The 6-month symptomatic data could support a New Drug Application (NDA) filing, with the full study continuing to evaluate the long-term impact on disease progression.
Maria Maccecchini, CEO of Annovis Bio, expressed excitement over the design, saying it brings them closer to providing a novel treatment for patients with early-stage Alzheimer's disease.
Currently, ANVS is trading at $5.14 down by 5.14%.
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