Annovis Bio (NYSE: ANVS), 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 that the FDA has accepted an updated protocol for the pivotal Phase 3 AD study, which is slated to begin in January 2025. In October 2024, the FDA granted clearance for Annovis to proceed with the pivotal Phase 3 AD studies based on its Phase 2/3 data demonstrating cognitive improvement in early-stage AD patients. The original protocol design proposed two separate trials that are now integrated into a single 6/18-month trial under the revised protocol.
“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. We are excited to move forward with this approach, which brings us closer to delivering a novel treatment to patients in need.”
To view the full press release, visit https://ibn.fm/suZ39
About Annovis Bio Inc.
Headquartered in Malvern, Pennsylvania, Annovis Bio Inc. is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit the company’s website at www.AnnovisBio.com and social channels LinkedIn, YouTube and X.
NOTE TO INVESTORS: The latest news and updates relating to ANVS are available in the company’s newsroom at https://nnw.fm/ANVS
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