Annovis Schedules FDA Meeting For Parkinson’s Disease Dementia Program While Reconfirming FDA Support For Pivotal Phase 3 Alzheimer’s Study

Annovis Bio, Inc., a late-stage clinical drug platform company developing innovative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), announced that the U.S. Food and Drug Administration (FDA) has scheduled a Type C meeting in January 2026. This meeting will focus on discussing the development pathway for Parkinson's disease dementia (PDD). The company also confirmed that its ongoing Phase 3 clinical trial in Alzheimer’s disease remains on track, with full regulatory alignment on its study design, patient criteria, and endpoints.

Maria Maccecchini, Ph.D., President and CEO of Annovis Bio, stated that the company is encouraged by the FDA’s proactive engagement on the PDD program. She noted that the scheduled meeting represents a significant step forward for the company’s pipeline and reinforces the potential of buntanetap—Annovis’ lead drug candidate—as a treatment option across multiple neurodegenerative conditions.

Parkinson’s disease dementia is a serious condition that affects around 30 percent of people with Parkinson’s disease, although some studies suggest that as many as 80 percent may eventually develop dementia over time. The condition dramatically impacts quality of life for patients and caregivers, and currently available treatments are limited. The upcoming FDA meeting will cover key elements of the clinical pathway for buntanetap in PDD, including trial design, patient population criteria, and potential routes for regulatory approval.

Cheng Fang, Senior Vice President of Research and Development, explained that PDD naturally aligns with Annovis’ broader research programs in Alzheimer’s and Parkinson’s disease. Across multiple clinical studies, buntanetap has shown potential in improving cognition, which could be especially valuable for Parkinson’s patients experiencing cognitive decline—an area that has historically received limited focus. He added that the data collected so far presents a strong opportunity to address this unmet medical need.

Alongside progress in its PDD discussions, Annovis confirmed that patient enrollment for its Phase 3 Alzheimer’s disease study is moving forward as planned. The company received thorough feedback from the FDA during its End-of-Phase 2 meeting in 2024, and the agency fully agreed with the study’s structure and goals. The Phase 3 trial is being designed to support two potential New Drug Applications (NDAs): one for symptomatic improvement and another for disease-modifying treatment with buntanetap.

Maria Maccecchini emphasized that the continued engagement from the FDA is an important indicator of the company’s strong regulatory standing. She reaffirmed Annovis’ commitment to advancing its lead program in Alzheimer’s disease while also pursuing additional opportunities in related conditions such as PDD, where buntanetap may offer meaningful benefits for patients.