Annovis Bio Inc. (NYSE: ANVS) Receives FDA Clearance to Initiate Pivotal Phase 3 Alzheimer’s Studies, Paving the Way for NDA Filings

• 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 initiation, fast-tracking the drug’s pathway to market.

No Safety Concerns:

During the FDA meeting, the FDA raised no concerns about data involving liver enzymes, drug interactions, pharmacokinetics, or dose selection, and approved the use of the drug’s new crystal form for all upcoming studies.

CEO Statement:

“We are now ready to move into the highly anticipated Phase 3 stage,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. “Our priority is to bring the treatment to patients as early as possible, and we are executing the next clinical trial at the highest standards to attain an expedited NDA submission.”

About Annovis Bio, Inc.

Based in Malvern, Pennsylvania, Annovis Bio is dedicated to addressing neurodegenerative diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, with the aim of restoring brain function and improving patients’ quality of life.

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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