MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) said it will begin enrolling patients in January 2026 in a large, long-term study designed to assess whether its experimental Parkinson’s disease drug can deliver sustained benefits over several years.
The company announced plans for an open-label extension study that will track the safety and effectiveness of buntanetap over a 36-month treatment period. The study is expected to enroll up to 500 patients across multiple sites in the United States, making it one of the company’s most ambitious clinical efforts to date.
Participants will receive once-daily oral doses of buntanetap, with the study structured to follow two distinct patient populations. One group will include patients who previously participated in Annovis-sponsored buntanetap trials, allowing researchers to examine how symptoms changed after treatment stopped and how patients respond when therapy is restarted. The second group will include patients who have undergone deep brain stimulation, a population often excluded from drug trials due to the complexity of measuring outcomes alongside implanted devices.
Chief Executive Officer Maria Maccecchini said the study responds directly to feedback from earlier Parkinson’s trials, in which patients reported perceived improvements and expressed interest in remaining on treatment. The extended follow-up is intended to provide a clearer picture of buntanetap’s long-term safety profile and its potential effects on both motor and cognitive symptoms.
The inclusion of patients receiving deep brain stimulation reflects a deliberate effort to study an underserved group within Parkinson’s research. Annovis said examining buntanetap alongside DBS could yield insights into how drug therapy and surgical intervention interact over time.
In addition to clinical assessments, the study will collect skin and plasma biomarkers to help researchers better understand disease progression and whether buntanetap may influence underlying disease mechanisms.
Annovis is focused on developing treatments for neurodegenerative diseases, including Parkinson’s and Alzheimer’s, where long-term disease modification remains a major unmet need. The company said data from the open-label extension could play a key role in shaping future regulatory and development decisions.
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