Buntanetap (ANVS401)

July 7, 2026: Annovis Bio, Inc. (NYSE: ANVS) reported full enrollment in its pivotal Phase 3 trial (NCT06709014) of oral buntanetap (30 mg daily) in early Alzheimer’s disease. The randomized, placebo-controlled, double-blind study enrolled 850 patients (exceeding the original goal) with pTau217-confirmed AD pathology across 83 U.S. clinical sites; eligibility included MMSE 20–28.

The trial has two pre-specified top-line readouts intended to support separate NDA submissions: a 6-month symptomatic analysis and an 18-month disease-modifying analysis. Primary endpoints assess cognition (ADAS-Cog13) and function (ADCS-iADL).

Upcoming catalysts/milestones:

• January 2027: last patient expected to complete the 6-month treatment period.
• Q1 2027: 6-month symptomatic top-line data readout.
• Q1 2028: 18-month disease-modifying top-line data readout.

Regulatory: The company said it has begun preparations for U.S. FDA NDA submissions, aiming to file shortly after each respective readout, based on prior FDA interactions and an FDA-aligned protocol.