Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company focused on developing therapies for neurodegenerative disorders such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), announced today that the U.S. Food and Drug Administration (“FDA”) has granted clearance to proceed with pivotal Phase 3 studies for buntanetap in early-stage Alzheimer’s patients. This decision follows a successful End-of-Phase 2 meeting held on Oct. 10, 2024, where Annovis and the FDA aligned on the next steps for advancing buntanetap toward New Drug Application (“NDA”) submissions.
The Phase 3 program will consist of two trials: a 6-month study aimed at confirming buntanetap’s symptomatic benefits and an 18-month study to explore potential disease-modifying effects. The company plans to initiate the first trial in Q1 2025, with the possibility of submitting an NDA based on the completion of the 6-month study.
“We are grateful for the FDA’s support in advancing our Phase 3 studies as planned,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. “This clearance marks an important step forward as we work to bring buntanetap to patients in need. Our team is preparing to launch the study early next year, and we will provide ongoing updates as we progress towards our goals.”
In the company’s previous Phase 2/3 study, buntanetap demonstrated significant cognitive improvements in early Alzheimer’s patients, while maintaining a strong safety profile. These positive results informed the Phase 3 trial design, positioning the company to further validate buntanetap’s efficacy and safety in a larger patient population.
To view the full press release, visit https://ibn.fm/YRUTs
About Annovis Bio Inc.
Annovis Bio, headquartered in Malvern, Pennsylvania, is committed to addressing neurodegeneration in diseases such as Alzheimer’s and Parkinson’s. The company is developing innovative therapies that target multiple neurotoxic proteins, with the goal of restoring brain function and improving the quality of life for patients.
For more information, visit the company’s website at www.AnnovisBio.com, and social channels LinkedIn, X and YouTube.
NOTE TO INVESTORS: The latest news and updates relating to ANVS are available in the company’s newsroom at https://ibn.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 75+ 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