BERWYN, PA — Annovis Bio (NYSE: ANVS) recently announced that the United States Patent and Trademark Office (USPTO) has granted the Company a patent with claims covering the use of Annovis Bio’s lead drug candidate, buntanetap, for the prevention and treatment of diseases caused by the disruption in heavy metal homeostasis.
U.S. Patent 11,596,621 B2 is titled, “Prevention or Treatment of Disease States Due to Metal Dis-homeostasis Via Administration of Posiphen [buntanetap] to Healthy or Sick Humans” and was issued on March 7, 2023. The patent is expected to confer protection for use of buntanetap and its related analogue molecules for the prevention and treatment of various neurodegenerative diseases associated with metal dis-homeostasis out to early 2040.
The ‘621 patent covers the use of buntanetap for maintaining or restoring heavy metal homeostasis as a method of prevention in healthy humans or as a method of treatment in sick humans. Metal dis-homeostasis, particularly iron, is a hallmark of various conditions including neurodegenerative diseases, cardiovascular diseases, cancer, and vital organ dysfunction (i.e., brain, heart, liver, lung, and/or kidney).
Iron plays a crucial role in many biological processes including translational regulation of neurotoxic proteins. In neurodegenerative diseases, such proteins include amyloid precursor protein (APP), amyloid-β, tau, α-synuclein, TDP-43, TSE, superoxide dismutase, huntingtin, prion, and c9orf72. The translation of these proteins are regulated by the iron regulatory protein 1 (IRP1) which binds a preserved sequence of mRNA. When this preserved sequence is bound to IRP1, the mRNA is prevented from attaching to the ribosome and being translated. An overload of iron leads to the release of the mRNA from IRP1 and to the translation of the mRNA by the ribosome resulting in the high levels of neurotoxic proteins. Annovis Bio’s lead drug candidate, buntanetap, inhibits the production of these neurotoxic proteins and therefore has broad clinical utility across a wide spectrum of neuro-inflammatory diseases, including Alzheimer’s disease and Parkinson’s disease.
“The basis for this newly issued U.S. patent is the ability of buntanetap to augment the binding of IRP1 to mRNA under high iron conditions preventing the translation of neurotoxic proteins and restoring homeostasis,” said Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis. “Expanding our intellectual property portfolio remains a key strategic focus of Annovis. By introducing buntanetap as a preventative and/or restorative agent for different diseases characterized by an imbalance in metal homeostasis, we seek to expand the IP protections surrounding the clinical utility of this unique and differentiated therapy across a broad range of diseases and conditions impacted by the disruption of heavy metal homeostasis.”
The ‘621 patent provides coverage for several aspects of treatment with buntanetap, preventing disease through chronic prophylactic use of buntanetap in healthy humans to maintain iron homeostasis, and use of the drug to restore iron homeostasis in sick humans.
Annovis Bio has patents that cover a wide range of chronic neurodegenerative as well as acute neurodegenerative diseases. It furthermore has patents covering neuropsychiatric disorders.
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