Annovis Bio Launches 36-Month Open-Label Extension Study for Buntanetap in Parkinson's Disease
核心洞察
Annovis Bio will initiate a 36-month open-label extension study in January 2026 to evaluate long-term safety and efficacy of buntanetap in 500 Parkinson's disease (搜索) patients.
The study includes two cohorts: former clinical trial participants and patients receiving deep brain stimulation therapy, addressing an underserved population in clinical research.
This extension study aims to help Annovis meet FDA patient exposure requirements for a future New Drug Application submission, targeting approximately 1,500 total treated patients.
Annovis Bio announced plans to launch a comprehensive 36-month open-label extension study for buntanetap in Parkinson's disease (搜索) patients, beginning enrollment in January 2026. The study (NCT07284784) will enroll 500 patients across multiple U.S. sites to evaluate the long-term safety and efficacy of the experimental neurodegeneration therapy.
"Launching the OLE study is a natural next step for our Parkinson's program," said Maria Maccecchini, Ph.D., President and CEO of Annovis Bio. "In our previous PD trial, many patients shared they experienced noticeable improvements and were eager to stay on treatment. Being able to offer them continued access to buntanetap truly matters to us."
Study Design and Patient Populations
The extension study will include two distinct patient cohorts receiving once-daily 30mg oral buntanetap over the 36-month treatment period. Cohort 1 will consist of former participants from previous buntanetap clinical studies, invited to continue treatment and assess long-term outcomes. Cohort 2 will include patients who have been receiving deep brain stimulation (DBS) treatment for at least 12 months following successful surgery.
The inclusion of DBS patients represents a significant development in Parkinson's research, as this population is frequently excluded from clinical trials. "Patients receiving DBS have long been underserved in clinical research, and this study represents an important opportunity to better understand how a new therapeutic option may support them," said Melissa Gaines, Senior VP of Clinical Operations at Annovis.
Evaluating Treatment Persistence and Disease Modification
For Cohort 1 participants, the study design allows Annovis to evaluate how patient outcomes evolved after discontinuing treatment from previous trials. This approach provides insight into whether treatment effects persist over time and how symptoms progress during treatment-free intervals. The study will also assess patient responses when treatment is reintroduced, offering a longitudinal view of buntanetap's effects and durability.
Maccecchini emphasized the study's broader scientific objectives: "By following patients over an extended period, we will further measure buntanetap's safety and evaluate its sustained benefits on both motor and cognitive functions. Collecting biomarker data will also help us deepen our understanding of buntanetap's potential as a disease-modifying treatment."
Regulatory Pathway and NDA Preparation
The extension study serves a critical role in Annovis's regulatory strategy, helping the company meet FDA patient exposure requirements for a future New Drug Application (NDA) submission. With more than 1,200 patients who have completed prior studies or are currently enrolled in the ongoing pivotal Phase 3 Alzheimer's disease (搜索) trial, the addition of the OLE study will enable Annovis to satisfy all required criteria.
The FDA requirements include a total of approximately 1,500 treated patients, at least 100 patients treated for one year, and 300-600 patients treated for six months at the final intended dose of 30 mg. The OLE study is designed to close this gap and ensure the company is fully prepared to advance buntanetap toward NDA submission.
Biomarker Collection and Disease Understanding
Throughout the 36-month study period, both cohorts will have skin and plasma biomarkers collected to deepen understanding of disease course and progression. This biomarker data collection aims to provide additional insights into buntanetap's mechanism of action and its potential to modify the underlying disease process in Parkinson's disease (搜索).
The study represents Annovis Bio's continued commitment to addressing neurodegeneration in both Alzheimer's and Parkinson's diseases. Comprehensive study information is available on the company's website and ClinicalTrials.gov, with patients encouraged to contact clinicaltrials@annovisbio.com for additional questions about participation.