Annovis Bio Initiates Three-Year Parkinson's Study as Part of Regulatory Strategy for Buntanetap

Annovis Bio, Inc. (ANVS) is gearing up for an extended clinical assessment of Buntanetap in Parkinson’s disease patients, with enrollment expected to commence in January 2026. The company plans to recruit approximately 500 participants across multiple U.S. medical centers for what will be a 36-month observational trial.

Study Design and Patient Population

The extension research will evaluate the 30 mg once-daily oral formulation of Buntanetap across two distinct participant groups. The first cohort will consist of individuals who previously enrolled in Buntanetap trials, allowing researchers to examine how disease markers change during treatment interruption and subsequent therapy resumption. This interruption-restart model offers unique insights into treatment durability.

The second cohort targets an often-excluded demographic: patients who have undergone deep brain stimulation (DBS) therapy for a minimum of 12 months. By assessing how Buntanetap performs alongside DBS, Annovis addresses a significant gap in clinical evidence for a patient population historically underrepresented in drug development research.

Research Objectives and Biomarker Analysis

Beyond safety and efficacy endpoints, the 36-month framework allows investigators to collect skin and plasma biomarkers that track disease progression markers. This longitudinal biomarker collection strengthens the dataset for understanding whether Buntanetap offers potential disease-modifying benefits—a critical distinction from symptomatic relief alone.

The trial design reflects Parkinson’s disease realities: as a progressive neurodegenerative condition affecting motor coordination and cognitive processing, the disease requires long-term therapeutic strategies. Current treatment options frequently offer incomplete symptom management, making extended efficacy data particularly valuable.

Regulatory and Commercial Implications

With more than 1,200 patients already exposed to Buntanetap across previous studies and the ongoing Phase 3 Alzheimer’s trial, this 36-month extension builds the patient exposure database necessary for FDA New Drug Application submission. Regulatory pathways require demonstrated safety and efficacy across sufficient patient numbers and treatment durations—requirements this extension meaningfully addresses.

Market Response

ANVS shares have fluctuated between $1.11 and $5.60 over the past 12 months. The stock closed the previous trading session at $3.67, reflecting a 1.38% gain, before advancing to $3.79 (up 3.27%) during after-hours trading.

Annovis positions this multi-year study as evidence of its commitment to Parkinson’s disease research and to enrolling underserved patient populations in clinical development programs.