Annovis Bio Inc. (NYSE: ANVS) Receives FDA Clearance To Initiate Pivotal Phase 3 Alzheimer's Studies, Paving The Way For NDA Filings

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• Annovis Bio received FDA clearance to move forward with Phase 3 trials for buntanetap following an End-of-Phase 2 meeting on October 10, 2024.
• The pivotal trials will investigate buntanetap's short-term symptomatic effects and potential long-term disease-modifying benefits in early-stage Alzheimer's disease (“AD”) patients.
• Annovis Bio is targeting potential NDA submission within one year of the study's initiation for symptomatic treatment, based on the results of a well-executed 6-month trial.
• The FDA raised no safety concerns regarding buntanetap and supported the use of its new crystal form in development.

Annovis Bio (NYSE: ANVS) , a late-stage clinical drug platform company focused on developing transformative therapies for neurodegenerative disorders, including Alzheimer's disease (“AD”) and Parkinson's disease (“PD”), recently announced a significant milestone in its drug development process. On October 10, 2024, the company held an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”), where it received clearance to proceed with pivotal Phase 3 studies for its lead compound, buntanetap.

Phase 3 Clinical Trials Overview:

• A 6-month study to confirm buntanetap's symptomatic effects in early-stage AD patients.
• An 18-month study aimed at evaluating its long-term potential as a disease-modifying treatment.

The first, 6-month study is slated to begin in Q1 2025. Notably, if the initial 6-month study yields positive results, it may support an NDA submission of buntanetap as a symptomatic treatment within a year of...

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The latest news and updates relating to ANVS are available in the company's newsroom at

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