Malvern, PA-based Annovis Bio, Inc. announced it will meet with the U.S. Food and Drug Administration (FDA) to discuss the company’s work on drugs to treat Alzheimer’s disease and Parkinson’s disease.
The company said it has scheduled a Type C meeting in January 2026 to talk with the FDA about its pathway for Parkinson’s disease dementia (PDD), as well as its Phase 3 Alzheimer’s disease (AD) clinical trial.
“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,” Maria Maccecchini, Ph.D., President and CEO, said. “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.”
Buntanetap works by inhibiting the production of several neurotoxic proteins at once, and studies show it may improve cognition and motor function in patients. Officials Annovis said the meeting with the FDA will focus on the clinical development pathway for buntanetap in PDD and 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,” Cheng Fang, Senior VP, Research & Development with Annovis, said. “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.”
The company also said it has full FDA agreement on all of the critical study parameters in its clinical trial over early AD. Officials with the company said the FDA provided feedback during a meeting in 2024 that confirming its alignment on the study design. That could support two potential treatments – one, a symptomatic treatment and one a disease-modifying treatment with buntanetap.
“The FDA’s continued engagement across our clinical programs underscores the regulatory clarity we have established,” Maria Maccecchini, Ph.D., said. “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.”