BioMedNewsBreaks – 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.”

To view the full press release, visit https://ibn.fm/WBCNu

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

About BioMedWire

BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.

BMW is where breaking news, insightful content and actionable information converge.

To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only)

For more information, please visit https://www.BioMedWire.com

Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/Disclaimer

BioMedWire
San Francisco, CA
www.BioMedWire.com
415.949.5050 Office
Editor@BioMedWire.com

BioMedWire is powered by IBN