Annovis Bio announced that the FDA has scheduled a Type C meeting in January 2026 to discuss the company's pathway for Parkinson's disease dementia (PDD). Annovis also reaffirmed that its ongoing Phase 3 AD clinical trial continues to progress with full regulatory alignment on study design, endpoints, and patient population.
"We are pleased with such proactive engagement with the FDA on our PDD program, which represents a significant opportunity to address an underserved patient population," said Maria Maccecchini, Ph.D., President and CEO. "The scheduled January meeting marks a key milestone for our pipeline, underscoring buntanetap's potential across multiple neurodegenerative indications and the strength of our scientific approach."
The upcoming meeting will focus on the clinical development pathway for buntanetap in PDD, a debilitating condition affecting approximately 30% of PD patients, with some reports suggesting that up to 80% develop dementia over the long term. Dementia in Parkinson’s profoundly affects quality of life for both patients and caregivers, with limited approved treatment options currently available. The meeting agenda will include discussions on clinical trial design, patient population, and a potential approval route.
"Parkinson's disease dementia represents a natural extension of both our Alzheimer's and Parkinson's programs," added Cheng Fang, Senior VP, Research & Development. "Across both indications, we have generated strong data demonstrating meaningful cognitive improvement with buntanetap. Despite being a serious problem, cognitive decline in Parkinson's patients has received limited attention in the field. Our integrated data across multiple studies has opened a unique opportunity to address this unmet need and alleviate the cognitive burden in the Parkinson's population."
This milestone builds directly upon recent biomarker findings that identified amyloid co-pathology in Parkinson's patients with more pronounced cognitive impairment, which was ultimately reversed by buntanetap. Read more about it in our newsroom.
Annovis also confirmed that its Phase 3 clinical trial in early AD continues to enroll patients according to plan, with full FDA agreement on all critical study parameters. The agency provided comprehensive feedback during the End-of-Phase 2 meeting in 2024, confirming its alignment on the study design, which is set to support two potential NDAs: one for symptomatic treatment and one for disease-modifying treatment with buntanetap.
"The FDA's continued engagement across our clinical programs underscores the regulatory clarity we have established," said Maria Maccecchini, Ph.D. "We remain focused on executing our pivotal Phase 3 AD study while advancing opportunities in complementary indications like PDD, where our drug candidate may provide a truly meaningful benefit to patients."
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