Annovis Announces Open-Label Extension Study for Parkinson's Disease Patients
Enrollment will begin in January 2026
Participants will be treated with buntanetap for 36 months
The study aims to enroll 500 patients
MALVERN, Pa., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE:ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced it will begin an Open-Label Extension (OLE) study in January 2026 to evaluate the long-term safety and efficacy of buntanetap in PD patients.
"Launching the OLE study is a natural next step for our Parkinson's program," said Maria Maccecchini, Ph.D., President and CEO. "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."
"At the same time, this study will allow us to take a longer-term view of buntanetap," she continued. "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."
Study overview (NCT07284784)
- Enrollment: 500 patients across multiple sites in the U.S.
- Duration: 36-month treatment period
- Treatment: Once-daily 30mg oral buntanetap
- Patient populations:
- Cohort 1: Former participants of buntanetap clinical studies (by invitation)
- Cohort 2: Patients receiving deep brain stimulation (DBS) treatment
Examining treatment persistence (Cohort 1)
By inviting participants from prior studies, Annovis aims to evaluate how patient outcomes evolved after discontinuing treatment, an important factor in understanding buntanetap's potential to alter the course of disease. This approach provides insight into whether treatment effects persist over time and how symptoms progress during a treatment-free interval.
In addition, the study will allow Annovis to assess how patients respond when treatment is reintroduced. Observing both the off-treatment and return-to-treatment phases offers a more complete, longitudinal view of buntanetap's effects and durability, helping to characterize its long-term impact across different stages of disease management.
Addressing an underserved population (Cohort 2)
In addition to former Annovis clinical trial participants, the study will also include patients who did not take part in earlier trials but have been receiving DBS for at least 12 months following successful surgery. By doing so, Annovis aims to understand how buntanetap works alongside DBS and the interaction between the two treatments.
This population is frequently excluded from clinical research, as electrical stimulation can complicate outcome assessments and make it difficult to isolate treatment effects. Through this OLE study, Annovis aims to help address this gap by offering these patients access to buntanetap, while also evaluating its safety and the potential to provide a meaningful additional benefit.
"We remain deeply committed to addressing areas of significant unmet medical need," said Melissa Gaines, Senior VP, Clinical Operations. "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."
For both cohorts, skin and plasma biomarkers will be collected to further deepen the understanding of the course and progression of the disease.
Advancing toward NDA readiness
The OLE PD study represents an important step toward a future New Drug Application (NDA) submission by helping Annovis meet the FDA's patient exposure requirements. With more than 1,200 patients who have completed prior studies or are currently enrolled in the ongoing pivotal Phase 3 AD trial, the addition of the OLE study will allow the Company to satisfy all required criteria: a total of ~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. By closing this gap, the OLE study reinforces the Company's readiness and ensures Annovis is fully prepared to advance buntanetap toward an NDA submission.
Participation information
Comprehensive study information is available on the Company's website and on ClinicalTrials.gov. For more questions, patients are encouraged to contact [email protected].
About Annovis
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD). The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.
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Forward-Looking Statements
This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company's SEC filings under "Risk Factors" in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.
Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com
Investor Contact:
Alexander Morin, Ph.D.
Director, Strategic Communications
Annovis Bio
[email protected]
