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Annovis Bio Highlights New Buntanetap Form In Phase 3 Alzheimer's Trial, Extends Patent Protection Into 2040s

Author: Benzinga Newsdesk | September 16, 2025 07:38am

Annovis Bio, Inc. (NYSE:ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced the publication of a new article in a peer-reviewed journal Biomolecules, which describes the pharmacokinetic (PK) profile of a new crystal form of buntanetap and compares it to the old form across several studies including mice, dogs, and humans.

The original anhydrous form of buntanetap has been used in all preclinical and clinical studies to date. Recently, the Annovis team identified a new dihydrate crystal, which incorporates two moles of water in its structure and offers greater stability. This publication examines how the new crystal form behaves in the body following oral administration, focusing on absorption and clearance. The findings confirm that crystal buntanetap preserves the PK profile and metabolism of the original form, which are essential for the drug's therapeutic efficacy.

 

"We have highlighted the new form of buntanetap in prior presentations, but this open-access publication presents the data in full to a broader audience. It not only validates the use of crystal buntanetap in clinical trials but also reinforces the consistency and reliability of our lead asset," said Alexander Morin, Ph.D., Director of Strategic Communications. "PK is central to understanding how a drug works, and we remain committed to rigorous analysis of buntanetap to ensure the most beneficial outcomes for patients."

The new crystal buntanetap is currently being used in the pivotal Phase 3 clinical trial (NCT06709014) in patients with early AD, which is actively enrolling participants across the U.S. The study is designed to deliver two key readouts: symptomatic (Fall 2026) and disease-modifying (Fall 2027). Moreover, this new form extends the intellectual property protection of the Company's lead compound into the 2040s, covering its mechanism of action, therapeutic use, and combination with other drugs.

Posted In: ANVS

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