Annovis Bio Advances Long-Term Buntanetap Evaluation: Three-Year Extension Study Signals Regulatory Push for Parkinson's Treatment

Annovis Bio, Inc. (ANVS) has unveiled plans for an ambitious multi-year clinical initiative designed to generate extended safety and efficacy data for Buntanetap in Parkinson’s disease management. The stock reflected investor optimism, closing at $3.67 yesterday with a 1.38% gain before climbing to $3.79 in after-hours trading, representing a 3.27% increase. Over the past 12 months, ANVS has fluctuated between $1.11 and $5.60.

Study Design and Patient Population Strategy

The planned three-year continuation study represents a strategic expansion of Annovis’ clinical evidence base. Enrollment is targeted to begin in January 2026, with the company seeking to recruit 500 participants across numerous U.S. medical centers. Each participant will receive a once-daily 30 mg oral dose of Buntanetap throughout the entire 36-month duration.

The protocol incorporates two distinct patient cohorts designed to address different clinical questions. The first group comprises individuals who participated in previous Buntanetap trials, allowing researchers to document symptom progression after treatment discontinuation and measure response patterns upon therapy resumption. The second cohort includes deep brain stimulation (DBS) patients who have maintained this intervention for a minimum of 12 months—a population traditionally underrepresented in Parkinson’s research due to exclusion criteria employed in standard trials.

Clinical and Regulatory Rationale

Parkinson’s disease remains a progressive neurological disorder characterized by deterioration in both motor control and cognitive abilities, with existing treatment options providing incomplete symptom management. This extended study framework seeks to characterize Buntanetap’s durability of benefit, long-term tolerability profile, and potential disease-modifying capacity through systematic biomarker collection from skin and plasma samples.

The initiative directly supports Annovis’ regulatory strategy. The company has already exposed more than 1,200 patients to Buntanetap across earlier studies and an ongoing Phase 3 Alzheimer’s trial. The additional patient exposure and treatment duration data from this three-year extension are anticipated to fulfill FDA requirements for comprehensive safety documentation and adequate dosing intervals necessary for a future New Drug Application submission.

Clinical Context

Previous Phase 3 Parkinson’s data, released last year, demonstrated that Buntanetap achieved statistically significant improvements in motor symptoms, non-motor manifestations, and cognitive function in early-stage disease patients. The current extension study reflects the company’s commitment to systematically addressing historical gaps in Parkinson’s disease research, particularly regarding patient populations that have been historically excluded or underrepresented in clinical development programs.