Annovis Bio said it will begin an open-label extension (OLE) study in January 2026 to evaluate the long-term safety and potential benefits of its investigational oral therapy buntanetap in patients with Parkinson’s disease. The study aims to enrol up to 500 participants and will treat them with once-daily 30 mg buntanetap over a 36-month period, focusing on both motor and cognitive outcomes.
The OLE will include two cohorts. Cohort 1 consists of former participants from prior Annovis Parkinson’s studies invited back to assess how outcomes evolve after treatment interruptions and when buntanetap is reintroduced. Cohort 2 will enrol patients who have been receiving deep brain stimulation (DBS) for at least 12 months to understand how buntanetap may work alongside DBS—a group often underrepresented in research. Biomarker data from plasma and skin will also be collected to deepen understanding of disease progression and treatment effects.
According to Annovis, the OLE study is designed to support broader regulatory objectives, including meeting FDA patient exposure requirements to advance buntanetap toward a New Drug Application (NDA). Combined with more than 1,200 patients treated in prior or ongoing trials, the extension should help satisfy criteria for long-term safety data needed for future submissions.
Buntanetap is being developed as a potential disease-modifying therapy for neurodegenerative disorders and has been studied in both Alzheimer’s disease and Parkinson’s disease clinical programmes. The new study reflects the company’s commitment to evaluating sustained therapeutic impact and safety over extended periods in a broader patient population.
