Annovis Bio Gears Up for Three-Year Buntanetap Trial: What This Means for Parkinson's Patients

Annovis Bio, Inc. (ANVS) is moving forward with an ambitious clinical initiative—a 36-month open-label extension study to evaluate how Parkinson’s disease patients sustain response to Buntanetap therapy over an extended period. For context, 36 months represents a full three years of continuous observation, a significant commitment in the drug development timeline.

Why This Study Matters

Parkinson’s disease remains one of the most challenging neurodegenerative conditions, impacting motor control, movement, and cognitive abilities simultaneously. Current treatment options frequently fall short in delivering comprehensive symptom management. By committing to a 36-month study horizon, Annovis is addressing a critical gap: understanding how experimental treatments perform when administered long-term, rather than over shorter trial windows.

Study Design and Patient Population

Beginning in January 2026, Annovis plans to recruit 500 patients across multiple U.S. clinical centers to receive once-daily Buntanetap at 30 mg doses throughout the entire 36-month period. The study uniquely incorporates two distinct patient cohorts:

Returning Patients: Individuals who previously participated in Buntanetap trials will be re-enrolled. Researchers will observe symptom changes during the treatment interruption and track how patients respond when therapy resumes—providing insights into treatment durability.

Deep Brain Stimulation Patients: A population typically excluded from research, patients already using DBS for a minimum of 12 months will be assessed for Buntanetap’s safety profile and efficacy alongside their existing treatment protocol.

Clinical and Regulatory Significance

The three-year data collection will track disease progression through skin and plasma biomarkers, while simultaneously documenting long-term safety and potential disease-modifying effects. More than 1,200 patients have already been exposed to Buntanetap across earlier studies and an ongoing Phase 3 Alzheimer’s trial, and this extension study will substantially increase the safety database—helping Annovis meet FDA prerequisites for New Drug Application approval.

Market Response

ANVS stock has demonstrated volatility over the past 12 months, trading within a $1.11 to $5.60 range. The stock closed the previous session at $3.67, reflecting a 1.38% gain, and climbed further to $3.79 in after-hours trading, representing a 3.27% increase.

The Phase 3 Parkinson’s trial results released last year showed Buntanetap to be both safe and effective in improving both motor and non-motor symptoms while enhancing cognitive function in early-stage Parkinson’s patients—laying groundwork for this extended observation phase.