Annovis Bio has achieved a significant intellectual property milestone by completing the full patent transfer for its crystalline form of buntanetap, securing comprehensive protection for both forms of its neurodegenerative disease drug candidate through 2046. The company announced that all patents have been successfully rewritten to cover the new crystal form while maintaining protection for the original semi-crystalline version.
Comprehensive IP Portfolio Expansion
The biotechnology company now maintains 13 patent families filed internationally, providing global coverage for buntanetap. This robust intellectual property portfolio encompasses patents protecting the composition of matter, mechanism of action, applications for multiple indications, and combinations with other therapeutic agents.
Building on its foundational patent for treating chronic neurodegenerative conditions, Annovis has systematically expanded its coverage to include patents for the original compound's use. The company has developed what it describes as comprehensive protection on two fronts: preserving the legacy of the semi-crystalline buntanetap and dedicating coverage to the crystalline form.
Enhanced Drug Formulation Properties
The company recently identified and characterized the new crystalline form of buntanetap, which demonstrates improved solid-state stability while maintaining comparable pharmacokinetic properties to the original formulation. Animal and human studies have established bioequivalence between both forms, showing identical systemic exposure profiles.
These research findings were presented at the Alzheimer's Association International Conference (AAIC) 2025 in Toronto, with the poster now available in the company's media library.
Clinical Development Progress
The FDA has approved the use of crystal buntanetap for Annovis's pivotal Phase 3 clinical trial in early Alzheimer's disease (NCT06709014), based on safety and pharmacokinetic data. The trial, initiated earlier this year, enrolls participants with MMSE scores of 21-28 who are pTau217-positive, receiving either placebo or crystal buntanetap daily for 18 months.
The study is actively underway with over 75 sites secured across the United States, with new patients entering weekly as the company works toward reaching its enrollment goal.
Strategic Implications
"This is a major milestone for our company," said Maria Maccecchini, Ph.D., President and CEO of Annovis. "With full IP protection now in place for both forms of buntanetap, we are well-positioned to continue its development and fully explore its therapeutic potential."
Maccecchini highlighted buntanetap's unique mechanism of action, which allows it to suppress multiple pathologies simultaneously. She noted potential advantages when the drug is complemented by other therapeutic agents such as GLP-1 agonists, PDE5 inhibitors, and statins, opening possibilities for pipeline expansions and broader clinical applications.
The intellectual property milestone positions Annovis to advance its late-stage clinical platform focused on transformative therapies for neurodegenerative diseases including Alzheimer's disease and Parkinson's disease.
