FDA Clears Annovis to Launch Pivotal Phase 3 Alzheimer’s Studies

 Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company developing transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), announced today the successful outcome of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on October 10, 2024. During the meeting, the FDA granted clearance to proceed with pivotal Phase 3 studies, based on the Company's Phase 2/3 clinical data showing symptomatic improvement in early AD patients. Annovis and the FDA have now aligned on a development path for buntanetap towards the filing of New Drug Applications (NDAs), one for short-term and one for long-term efficacy.

The Phase 3 program will investigate buntanetap in patients with early AD and will consist of two trials: a 6-month study aimed at confirming buntanetap’s symptomatic effects and an 18-month study designed to demonstrate potential disease-modifying effects. While the Company plans to run both studies, the completion of a well-designed and well-executed 6-month trial may be sufficient to support an NDA filing, potentially within one year of the study’s initiation.

https://www.globenewswire.com/news-release/2024/10/15/2963101/0/en/FDA-Clears-Annovis-to-Launch-Pivotal-Phase-3-Alzheimer-s-Studies-Paving-the-Way-to-NDAs.html