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
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