Annovis Bio completes enrollment in Phase 3 buntanetap trial for early Alzheimer's

Annovis Bio, Inc. announced on July 7, 2026 that it had reached full enrollment of its pivotal Phase 3 trial (NCT06709014) evaluating buntanetap in patients with early AD¹. The trial enrolled 850 patients with pTau217-confirmed AD pathology across 83 clinical sites in the US.¹

The study is structured as a randomized, placebo-controlled, double-blind dual clinical trial designed with two pre-specified readouts: a 6-month analysis of symptomatic effects and an 18-month analysis of disease-modifying effects of daily oral buntanetap (30mg)¹. The trial has recruited patients diagnosed with early AD (MMSE 20-28) who are positive for blood biomarker pTau217, which indicates Alzheimer's pathology in the brain.¹ The primary endpoints will assess changes in cognition (ADAS-Cog13) and function (ADCS-iADL).¹ This dual design will produce two distinct data readouts, each intended to support a separate regulatory submission for a New Drug Application (NDA).¹

On the timeline, the last patient is expected to complete the 6-month treatment period in January 2027, followed by data cleaning and analysis, with a 6-month symptomatic top-line data readout anticipated in Q1 2027 and an 18-month disease-modifying top-line data readout in Q1 2028¹. The company said it has already begun preparations for NDA submissions to the FDA, building on guidance received during prior FDA interactions, to position Annovis for submission shortly after each respective readout¹.

Company executives highlighted the enrollment growth. Sarah MacCallum, VP of Clinical Operations, said this time last year, the trial had 50 patients enrolled, and today the number stands at 850¹.

Buntanetap, previously known as posiphen, is described as an investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins, including APP and amyloid beta, tau, alpha-synuclein, and TDP-43, through a specific RNA-targeting mechanism of action¹.