Annovis Bio, Inc. has achieved full enrollment of 850 patients in its pivotal Phase 3 trial evaluating buntanetap for early Alzheimer's disease. The trial, conducted across 83 clinical sites in the US, exceeded its original enrollment goal and targets patients with pTau217-confirmed AD pathology. This milestone sets the stage for two distinct data readouts intended to support separate regulatory submissions for a New Drug Application (NDA).

The randomized, placebo-controlled, double-blind trial is designed with a dual analysis structure. It will assess symptomatic effects at 6 months and disease-modifying effects at 18 months using a daily oral dose of buntanetap (30mg). Patients diagnosed with early AD (MMSE 20-28) and positive for the blood biomarker pTau217 were recruited. Primary endpoints focus on changes in cognition via ADAS-Cog13 and function via ADCS-iADL.

Maria Maccecchini, Ph.D., Founder, President and CEO of Annovis, attributed the enrollment success to the trust of patients and families. She highlighted the trial design and execution led by Cheng Fang, Ph.D., CSO, and Sarah MacCallum, VP, Clinical Operations. The team emphasized adherence to high standards throughout the study.

Key Milestones

With the last patient expected to finish the 6-month treatment period in January 2027, Annovis has outlined the following timeline:

Preparations for NDA submissions to the U.S. Food and Drug Administration (FDA) are already underway, leveraging prior regulatory guidance. Cheng Fang noted that high enrollment strengthens the statistical power of the dataset, while Sarah MacCallum reflected on the rapid progress from 50 patients a year ago to 850 today.