Healthcare
Annovis Reaches Full Enrollment in Pivotal Phase 3 Trial of Buntanetap for Early Alzheimer’s Disease
Pivotal Phase 3 trial enrolls 850 patients, exceeding original projections Study completion on track: symptomatic data readout - Q1 2027, disease-modifying data readout - Q1 2028 Company positions for two NDA submissions following each readout MALVERN, Pa., July 07, 2026 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzh
About this update from Annovis Bio, Inc.
Pivotal Phase 3 trial enrolls 850 patients, exceeding original projections Study completion on track: symptomatic data readout - Q1 2027, disease-modifying data readout - Q1 2028 Company positions for two NDA submissions following each readout MALVERN, Pa., July 07, 2026 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced full enrollment of its pivotal Phase 3 trial ( NCT06709014 ) evaluating buntanetap in patients with early AD. The trial enrolled 850 patients with pTau217-confirmed AD pathology across 83 clinical sites in the US. "Reaching this level of enrollment, well above our original goal, reflects the trust patients and families living with this disease have placed in our work, and that is not something we take for granted," said Maria Maccecchini, Ph.D., Founder, President and CEO of Annovis. "This achievement is the product of outstanding trial design, management, and execution led by Cheng Fang, our CSO, and Sarah MacCallum, our VP of Clinical Operations, built from the ground up. I am deeply grateful to them and the entire Annovis team for their professionalism and passion in conducting this study according to the highest standards." The pivotal Phase 3 AD study is 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). 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. The primary endpoints will assess changes in cognition (ADAS-Cog13) and function (ADCS-iADL). This dual design will produce two distinct data readouts, each intended to support a separate regulatory submission for a New Drug Application (NDA). Next Milestones With the last patient expected to complete the 6-month treatment period in January 2027, followed by data cleaning and analysis, Annovis anticipates the following near-term milestones: