Annovis reached full enrollment in its pivotal Phase 3 buntanetap trial, enrolling 850 pTau217‑confirmed early AD patients across 83 U.S. sites.
Key Highlights:
- Phase 3 trial (NCT06709014) fully enrolled 850 patients with pTau217‑confirmed early Alzheimer’s disease.
- Dual readouts planned: 6‑month symptomatic top‑line data in Q1 2027 and 18‑month disease‑modifying data in Q1 2028.
- Trial is randomized, placebo‑controlled, double‑blind; primary endpoints are ADAS‑Cog13 and ADCS‑iADL.
- Annovis is preparing separate NDA submissions to FDA following each respective data readout.
Original SEC Filing:
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