MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) has completed enrollment in its pivotal Phase 3 Alzheimer’s disease trial, positioning the biotechnology company for two planned U.S. regulatory submissions beginning next year if the study produces positive results.
The company said the trial enrolled 850 patients with pTau217-confirmed early Alzheimer’s disease across 83 clinical sites in the United States, exceeding its original enrollment target.
The randomized, double-blind, placebo-controlled study is evaluating buntanetap, the company’s investigational oral therapy for Alzheimer’s disease.
The trial is designed with two pre-specified analyses: a six-month evaluation measuring symptomatic effects and an 18-month evaluation assessing whether the treatment modifies disease progression.
Primary endpoints will measure changes in cognition using the ADAS-Cog13 scale and functional ability using the ADCS-iADL assessment.
Annovis expects the last enrolled patient to complete the six-month treatment period in January 2027.
The company says it anticipates reporting top-line symptomatic data during the first quarter of 2027, followed by disease-modifying data in the first quarter of 2028.
Annovis said it has begun preparing New Drug Application submissions to the U.S. Food and Drug Administration and intends to file applications following each data readout, building on prior discussions with the agency.
Chief Scientific Officer Cheng Fang added that enrolling more participants than originally planned increases the statistical power of the study.
“Combined with the FDA-aligned protocol, we are executing this trial according to regulatory requirements as we approach this important moment for our company and the Alzheimer’s community,” Fang said.
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