Clinical TrialJul 10, 2026, 06:07 AM
Annovis Bio reaches full enrollment in pivotal Phase 3 AD trial
AI Summary
Annovis Bio, Inc. announced full enrollment of its pivotal Phase 3 trial evaluating buntanetap in patients with early Alzheimer's disease (AD). The trial successfully enrolled 850 patients with pTau217-confirmed AD pathology across 83 clinical sites in the US, exceeding original projections. The company anticipates a 6-month symptomatic data readout in Q1 2027 and an 18-month disease-modifying data readout in Q1 2028, with preparations underway for two separate NDA submissions to the FDA.
Key Highlights
- Annovis Bio reached full enrollment in its pivotal Phase 3 trial (NCT06709014) for buntanetap in early Alzheimer's disease.
- The trial enrolled 850 patients, exceeding original projections, across 83 clinical sites in the US.
- Patients had pTau217-confirmed AD pathology and early AD (MMSE 20-28).
- Symptomatic top-line data readout (6-month analysis) is anticipated in Q1 2027.
- Disease-modifying top-line data readout (18-month analysis) is anticipated in Q1 2028.
- The company is preparing for two separate New Drug Application (NDA) submissions to the FDA following each readout.
- Primary endpoints will assess changes in cognition (ADAS-Cog13) and function (ADCS-iADL).
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