Annovis Bio, Inc. (Annovis), a phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), announced that the United States Patent and Trademark Office (USPTO) has issued US Patent No. 12,780,831, titled “Solid Forms of Posiphen D-Tartrate.”
The patent contains eleven claims directed at the new crystalline form of buntanetap, designated Form B. The claims cover the Form B solid form, as characterized by its X-ray powder diffraction pattern and crystal unit cell, and at high purity levels – greater than 99.5% as determined by high-performance liquid chromatography (HPLC). The claims also cover methods of preparing Form B from earlier anhydrous Form A as well as pharmaceutical compositions containing Form B and a pharmaceutically acceptable carrier.
“Securing composition of matter protection for the new crystal form of buntanetap is an important milestone for Annovis,” said Maria Maccecchini, Ph.D., founder, president and CEO of Annovis. “This patent covers the form of buntanetap (Form B) that we have moved into our clinical programme, and it strengthens our position as we approach the readout of our pivotal phase 3 Alzheimer’s study and prepare for regulatory submissions that will follow.”
The patent provides Annovis with protection of buntanetap Form B through June 21, 2044.
As described in the patent, Form B is a highly crystalline dihydrate, while the previously used Form A is a semi-crystalline anhydrate. The two forms do not readily interconvert and have distinct crystalline phases. Form B was characterized as a robust and stable dihydrate: it does not lose water or change form when dried under vacuum, and it shows no change in form or crystallinity after milling. An HPLC analysis reported 99.9% purity of Form B.
The pharmacokinetic comparison of Form B with Form A across mice, dogs and humans revealed comparable profiles for both forms in plasma, brain, and cerebrospinal fluid. The results were submitted to the FDA and have been published in a peer-reviewed manuscript in Biomolecules journal.
Background:
• In June 2024, Annovis announced the filing of a composition of matter patent application for new solid forms of buntanetap.
• In July 2024, the Company announced that the US Food and Drug Administration (FDA) cleared the transition to the new crystalline form in future clinical trials, after reviewing bridge studies comparing Form A with Form B, together with data on the Company’s new large-scale manufacturing process for that form.
• On November 3, 2026, Annovis was granted US Patent No. 12,780,831 which covers the new crystalline form of buntanetap (Form B) that is used in the company’s ongoing clinical trials.
Annovis has completed enrollment in its pivotal phase 3 trial (NCT06709014) evaluating once-daily oral buntanetap (Form B, 30 mg) in patients with early AD who are positive for the plasma biomarker pTau217. The trial is designed with two pre-specified readouts: a 6-month analysis of symptomatic effects and an 18-month analysis of disease-modifying effects. The company expects the symptomatic top-line data readout in Q1 2027 and the disease-modifying readout in Q1 2028. Annovis has begun preparation for New Drug Application (NDA) submissions that will follow each readout.
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. is a phase 3 clinical-stage biotechnology company developing treatments for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD). The company’s lead drug candidate, buntanetap (formerly posiphen), is an investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins, including APP and amyloid beta, tau, alpha-synuclein, and TDP-43, through a specific RNA-targeting mechanism. By addressing the underlying causes of neurodegeneration, Annovis aims to halt disease progression and improve cognitive and motor functions in patients.
