Annovis Bio Inc. has completed enrollment in its pivotal Phase 3 trial of Buntanetap for early Alzheimer’s disease, enrolling 850 patients with pTau217-confirmed AD pathology across 83 US clinical sites.
The randomized, placebo-controlled, double-blind dual trial evaluates daily oral Buntanetap 30 mg with two pre-specified readouts: a six-month analysis of symptomatic effects and an 18-month analysis of disease-modifying effects.
Primary endpoints will assess changes in cognition (ADAS-Cog13) and function (ADCS-iADL). The study recruited patients with early AD defined by MMSE scores of 20 to 28 and positive blood biomarker pTau217.
With the last patient expected to complete the six-month treatment period in January 2027, Annovis projects a top-line symptomatic data readout in Q1 2027 and an 18-month disease-modifying readout in Q1 2028.
According to the company, preparations are underway for separate NDA submissions to the U.S. Food and Drug Administration following each readout.
Annovis is a Phase 3 clinical-stage biotechnology company headquartered in Malvern, Pennsylvania, developing Buntanetap for neurodegenerative diseases including Alzheimer’s and Parkinson’s disease.
