Annovis Secures Buntanetap Crystal-Form Patent Through 2044 Ahead of Phase 3 Alzheimer’s Readout

Key Points

• Annovis received a U.S. patent covering buntanetap Form B, the crystalline form used in its ongoing Alzheimer’s and Parkinson’s studies.
• The patent covers the solid form, pharmaceutical compositions and preparation methods, with protection extending through June 21, 2044.
• The fully enrolled Phase 3 Alzheimer’s trial has a symptomatic readout expected in the first quarter of 2027 and a disease-modifying readout expected in the first quarter of 2028.
• The patent strengthens intellectual property protection but does not establish clinical efficacy or regulatory approval.

Annovis Bio (NYSE: ANVS) announced a new patent protecting the form of its lead candidate, buntanetap, now used in its clinical program.

U.S. Patent No. 12,780,831, titled “Solid Forms of Posiphen D-Tartrate,” contains 11 claims covering Form B, including its crystalline characteristics, high-purity forms, preparation methods and pharmaceutical compositions.

Protection Covers the Form Used in Current Trials

Form B is a highly crystalline dihydrate, distinct from the previously used semi-crystalline, water-free Form A. According to Annovis, testing showed that Form B remained stable after vacuum drying and milling, supporting its suitability for manufacturing.

The company also reported comparable drug-exposure profiles between the two forms in bridging studies. The FDA cleared the transition to Form B for future clinical trials in July 2024 after reviewing those studies and manufacturing data. That clearance concerned the formulation change—not approval to market buntanetap.

For investors, the patent’s significance is that it protects the specific form being advanced toward potential commercialization. It should not be interpreted as blanket protection against every possible buntanetap formulation.

Phase 3 Results Remain the Main Catalyst

Annovis has completed enrollment in its pivotal Phase 3 study evaluating once-daily oral buntanetap Form B at 30 mg in patients with early Alzheimer’s disease who test positive for the plasma biomarker pTau217.

The trial has two prespecified readouts: a six-month analysis of symptomatic effects, expected in the first quarter of 2027, and an 18-month analysis of disease-modifying effects, expected in the first quarter of 2028.

The company says it has begun preparing for potential New Drug Application submissions following those readouts. The patent announcement does not establish that the results will support filing or approval.

Investor Takeaway

The patent strengthens Annovis’ potential commercial position ahead of an important clinical milestone, providing protection for Form B through 2044.

However, it is an intellectual property development rather than new evidence that buntanetap works. The near-term investment case remains centered on the 2027 symptomatic readout, followed by longer-term data assessing potential disease modification.