Annovis Bio Announces Full Enrollment Of Its Phase 3 Trial Of Buntanetap In Patients With Early Alzheimer’s Disease; The Trial Enrolled 850
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 MacCal...
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. , 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. " 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). S. , CSO at Annovis.
"High enrollment also strengthens the statistical power of our dataset. " "This time last year, our trial had 50 patients enrolled; today, the number stands at 850. We want to thank every patient, caregiver, and investigator who made this progress possible," said Sarah MacCallum, VP, Clinical Operations at Annovis. "