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Posted On: 01/07/2025 4:48:01 PM
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NetworkNewsBreaks – Annovis Bio Inc. (NYSE: ANVS) Announces Streamlined Pathway to Advance Buntanetap for AD
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.”
NOTE TO INVESTORS: The latest news and updates relating to ANVS are available in the company’s newsroom at https://nnw.fm/ANVS
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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.”
NOTE TO INVESTORS: The latest news and updates relating to ANVS are available in the company’s newsroom at https://nnw.fm/ANVS
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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