Annovis Bio, Inc. (ANVS) is preparing to launch a long-term open-label extension study to observe how Parkinson's disease patients respond to continued treatment with Buntanetap over three years.
Parkinson's disease is a progressive neurodegenerative condition that affects both motor and cognitive function, and current therapies often provide only partial symptom control. Long-term data remains a key need as companies work to understand how emerging treatments perform over extended periods.
The new study, scheduled to being enrollment in January 2026, aims to enroll 500 patients across multiple U.S. sites. All participants will receive once-daily oral Buntanetap at 30 mg for 36 months.
The trial will include two groups:
Cohort 1: Former participants from earlier Buntanetap studies. Annovis intends to evaluate how symptoms changed after stopping therapy and how patients respond when treatment is restarted.
Cohort 2: Patients who have been receiving deep brain stimulation (DBS) for at least 12 months. This population is often excluded from clinical research, and the company aims to assess Buntanetap's safety and potential benefits alongside DBS.
By following patients through both off-treatment and return-to-treatment phases, the study is designed to provide insight into Buntanetap's long-term safety, durability of effect, and potential disease-modifying properties. Skin and plasma biomarkers will also be collected to track disease progression.
The extension study also supports Annovis' preparations for a future New Drug Application. With more than 1,200 patients already treated in prior studies or in the ongoing Phase 3 Alzheimer's trial, the additional exposure is expected to help the company meet FDA requirements for total patient numbers and duration of treatment at the intended dose.
Annovis states that the study reflects its commitment to addressing unmet needs in Parkinson's disease, among patients who have historically been underrepresented in clinical trials.
In a Phase 3 Parkinson's disease, the results of which were reported last year, Buntanetap was found to be safe and effective in improving motor and non-motor activities and improving cognitive functions in patients with early Parkinson's disease.
ANVS has traded between $1.11 and $5.60 over the past year. The stock closed yesterday's trading at $3.67, up 1.38%, and rose further in overnight trading to $3.79, up 3.27%.
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