Annovis Bio Inc. (NYSE: ANVS) has announced that the FDA has accepted an updated protocol for its pivotal Phase 3 Alzheimer's disease (AD) study, expected to commence in January 2025. This agreement streamlines the development pathway for buntanetap, a drug being investigated for both Alzheimer's and Parkinson's diseases.
Streamlined Phase 3 Trial Design
In October 2024, the FDA granted clearance for Annovis to proceed with Phase 3 AD studies based on Phase 2/3 data demonstrating cognitive improvement in early-stage AD patients. The original protocol included a 6-month symptomatic study and an 18-month disease-modifying study. The revised protocol integrates these into a single 6/18-month trial. This will include a 6-month data readout focused on symptomatic effects, followed by an additional 12-month assessment to evaluate the disease-modifying potential of buntanetap.
"This consolidated protocol will accelerate the development timeline while maintaining the scientific rigor necessary to advance buntanetap as a treatment for AD," said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. "With this design, we can leverage the 6-month symptomatic data to potentially support a New Drug Application (NDA) filing, all while continuing the same study seamlessly to assess long-term disease-modifying outcomes."
Buntanetap's Potential in Neurodegenerative Diseases
Buntanetap, previously known as ANVS401 or Posiphen, is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs). Its mechanism of action aims to reduce levels of neurotoxic proteins, thereby reducing toxicity in the brain. A Phase 2a clinical trial in AD and Parkinson's disease patients showed that buntanetap led to statistically significant improvement in motor function in PD patients and cognition in AD patients. The drug was also well-tolerated and safe.
Parkinson's Disease Program
Annovis Bio is also advancing the development of buntanetap for Parkinson's disease (PD). The FDA has indicated that the company may proceed with a Phase 3 clinical study of buntanetap for the treatment of Parkinson's disease. The FDA accepted the final protocol and the clinical development plan, approved the use of the company's new large-scale batch of good manufacturing practice material, and found the chronic toxicology in rats and dogs safe and adequate to support long-term human studies.
"We are pleased that the FDA has approved our clinical trial design in early PD patients and called it a well-designed study," said Maria L. Maccecchini, Ph.D. "The positive FDA review affirms the Company's path to securing approval for buntanetap to treat neurodegenerative diseases, including Parkinson's and Alzheimer's diseases, with longer treatment regimens."
