MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) has published new research in the journal Biomolecules detailing the pharmacokinetic profile of a new crystal form of buntanetap, its lead drug candidate for Alzheimer’s disease.
Buntanetap, previously developed in its original anhydrous form, has been used in all preclinical and clinical studies to date. The company’s researchers have now developed a dihydrate crystal form, which incorporates two moles of water into its structure, providing greater stability.
The study compared the two forms of buntanetap across animal and human studies, focusing on how the drug is absorbed and cleared from the body. Results confirmed that the crystal form maintains the same pharmacokinetic profile and metabolism as the original, an important factor in preserving 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,” said Alexander Morin, Ph.D., Director of Strategic Communications at Annovis. “It not only validates the use of crystal buntanetap in clinical trials but also reinforces the consistency and reliability of our lead asset. 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 crystal form is now being used in Annovis’ pivotal Phase 3 clinical trial (NCT06709014), which is enrolling patients with early-stage Alzheimer’s disease across the U.S. The trial is expected to deliver two key readouts: a symptomatic outcome in fall 2026 and a disease-modifying outcome in fall 2027.
Beyond clinical benefits, the new form also extends patent protection of buntanetap into the 2040s, covering its mechanism of action, therapeutic use, and potential combinations with other therapies.
The full article is available online through Biomolecules and on Annovis Bio’s website.
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