NetworkNewsBreaks – Annovis Bio Inc. (NYSE: ANVS) Receives FDA Clearance for Pivotal Phase 3 Alzheimer’s Trial, Launch Set for Early 2025
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.
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 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.
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
