MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) has announced that the U.S. Food and Drug Administration (FDA) has accepted an updated protocol for the company’s pivotal Phase 3 Alzheimer’s (AD) clinical trial. The study is set to launch in January 2025 and represents a significant step forward in developing treatments for early-stage AD.
The FDA had previously granted clearance in October 2024 for Annovis to proceed with its pivotal Phase 3 studies, following promising Phase 2/3 data showing cognitive improvements in early-stage patients. Initially, the company planned two separate trials spanning 6 months and 18 months to evaluate symptomatic and disease-modifying effects, respectively. However, the newly approved protocol integrates these into a single 6/18-month study.
This combined design will first produce a 6-month data readout to assess symptomatic improvement and then continue seamlessly to evaluate the long-term disease-modifying impact of buntanetap over 18 months.
According to Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis, “This consolidated protocol will accelerate the development timeline while maintaining the scientific rigor necessary to advance buntanetap as a treatment for AD. We can leverage the 6-month symptomatic data to potentially support a New Drug Application (NDA) filing while continuing to assess long-term outcomes.”
This innovative approach not only streamlines the research process but also offers new hope for advancing treatment options for Alzheimer’s, a progressive neurodegenerative disease that affects millions worldwide. Annovis’ approach could bring meaningful change to patient outcomes and the wider field of Alzheimer’s care.
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