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Annovis Completes Full Patent Transfer to Crystal Buntanetap

Key Takeaway: Annovis Bio, Inc. has completed the full patent transfer for its drug candidate, buntanetap, securing comprehensive intellectual property protection that extends to 2046. This includes protections for both the new crystalline form and the original semi-crystalline form, covering 13 patent families internationally. The company has characterized the new crystalline form with improved stability and demonstrated bioequivalence with the original form in studies. Additionally, the FDA approved the new crystalline form for use in a Phase 3 clinical trial targeting early Alzheimer's disease, enhancing its market position and potential applications.

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POSITIVE FACTORS

  • Comprehensive IP protection for both crystalline and semi-crystalline forms of buntanetap.
  • Successful completion of patent transfer enhances their IP portfolio until 2046.
  • Improvements in the new crystalline form can enhance clinical applications.
  • FDA approval for Phase 3 clinical trial demonstrates regulatory support.

Full Press Release Details

Annovis achieves comprehensive intellectual property (IP) protection now covering both the original semi-crystalline and new crystalline forms of buntanetap.
Both forms are covered by a total of 13 patent families.
All patents are filed internationally, securing global coverage of buntanetap.
MALVERN, Pa., Aug. 07, 2025 (GLOBE NEWSWIRE) -- 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 that all Company’s patents have been successfully transferred from the original form of buntanetap and rewritten to cover the new crystal form. Every patent family is now represented for both forms of the Company’s drug candidate, securing comprehensive protection, which extends to 2046.
Building on its foundational patent for the treatment of chronic neurodegenerative conditions, the Company has systematically expanded its coverage to include patents for the use of the original compound. Since then, Annovis has developed a robust IP portfolio which includes patents protecting the composition of matter, mechanism of action, applications of buntanetap for multiple indications, and its combination with other drugs.
Recently, the Company identified and characterized a new crystalline form of buntanetap with improved solid-state stability and comparable pharmacokinetic (PK) properties. A series of animal and human studies demonstrated the bioequivalence of both forms of buntanetap as they exhibit identical systemic exposure. These findings were presented at the Alzheimer’s Association International Conference (AAIC) 2025 in Toronto, and the poster is now available in the Media Library on the Company’s website.
Annovis previously secured protection for the composition of matter and manufacturing process of the crystalline form. However, as of this month, the Company has successfully completed the transfer of all IP inventions, extensions, and combinations from the original buntanetap to the new form, ensuring comprehensive coverage of its drug candidate on two fronts: one preserving the legacy of the semi-crystalline buntanetap (pink) and the other dedicated to the crystalline form (blue).
“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. Buntanetap’s unique mechanism of action allows it to suppress multiple pathologies simultaneously, and it may offer even better advantages when complemented by other drugs such as GLP-1 agonists, PDE5 inhibitors, and statins. This opens doors to possible pipeline expansions and broader clinical applications as part of our strategic growth.”
This IP milestone for crystal buntanetap complements another significant step – last year the FDA approved the use of the new form for the pivotal Phase 3 clinical trial in early AD (NCT06709014), based on its safety and PK data. The trial was initiated earlier this year with participants (MMSE 21-28, pTau217+) receiving either placebo or crystal buntanetap daily for 18 months. The study is actively underway with over 75 sites secured across the US and more patients entering each week, bringing us closer to reaching our enrollment goal by day. To find more information about the study, visit our updated Patient Portal or the official ClinicalTrials.gov page.
Forward-Looking Statements
This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.
Contact Information:
101 Lindenwood Drive
Alexander Morin, Ph.D.
Director, Strategic Communications

Frequently Asked Questions

What forms of buntanetap does Annovis protect?

Annovis protects both the original semi-crystalline and new crystalline forms of buntanetap.

How many patent families cover buntanetap?

Buntanetap is covered by a total of 13 patent families.

What diseases does Annovis target with its therapies?

Annovis focuses on treating neurodegenerative diseases like Alzheimer's and Parkinson's.

What is the significance of the IP milestone for Annovis?

The IP milestone ensures comprehensive protection for both forms of buntanetap until 2046.

What clinical trial is currently underway for buntanetap?

A pivotal Phase 3 clinical trial for early Alzheimer's disease is currently in progress.

Last updated: Aug 7, 2025