Annovis Bio Announces Issuance of U.S. Patent Covering the Use of Lead Drug Candidate, Buntanetap, for Prevention or Treatment of Disease States Due to Metal Dis-Homeostasis in Healthy or Sick Humans

BERWYN, Pa., April 27, 2023 (GLOBE NEWSWIRE) -- (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company developing treatments for neurodegenerative diseases announced today 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.

About Buntanetap
Buntanetap (previously known as ANVS401 or Posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs) which play a role in axonal injury, inflammation, and cell death. By targeting these mechanisms, buntanetap was shown to improve cognitive functions in patients with different neurodegenerative disorders. In Phase 2a clinical trial in AD and PD patients, buntanetap was well-tolerated and safe, and resulted in statistically significant improvement in motor function in PD patients and cognition in AD patients.

About Annovis Bio, Inc.
Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's disease (AD), Parkinson's disease (PD), and other chronic neurodegenerative diseases. We believe that we are the only company developing a drug for AD and PD that is designed to inhibit more than one neurotoxic protein and has a mechanism of action designed to restore axonal and synaptic activity. By improving brain function, our goal is to treat memory loss and dementia associated with AD as well as body and brain function associated with PD. Annovis conducted two Phase 1/2 studies: one in AD patients and one in both AD and PD patients. In the AD/PD study buntanetap showed improvements in cognition in AD as well as body and function in PD patients.

For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and Twitter.

Forward-Looking Statement
This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials and projections regarding the use of and need for capital. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding patient enrollment, the effectiveness of Buntanetap, the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety and tolerability of Buntanetap, and the timing of costs required to fund the Company's operations including such clinical trials. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Media Contact
Nic Johnson
Russo Partners, LLC 
(303) 482-6405
nic.johnson@russopartnersllc.com

Investors Contact:
Chris Calabrese
LifeSci Advisors, LLC
+1 (917) 680-5608
ccalabrese@lifesciadvisors.com

Kevin Gardner
+1 (617) 283-2856
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com

SOURCE Annovis Bio