Annovis Bio Announces Filing of Patent Covering the Administration of Buntanetap and Its Analogues for the Treatment of Mental Illnesses

BERWYN, Pa., Feb. 1, 2023 /PRNewswire/ -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company addressing Alzheimer's and Parkinson's disease announced today the filing of a patent application that extends the breadth of its platform from neurodegenerative to neuropsychiatric indications: "Treatment of mental illness via administration of buntanetap and analogues."

Five major mental illnesses — autism, attention deficit-hyperactivity disorder, bipolar disorder, major depressive disorder, and schizophrenia — appear to share some commonalities: dysregulation of Abeta and other neurotoxic protein synthesis similar to neurodegenerative diseases¹, dysfunctional nerve cell transmission and communication, and genetic risk factors according to an examination of genetic data from more than 60,000 people worldwide².

For the purposes of the present patent application, these commonalities are presented to demonstrate that many of these disorders show abnormal patterns of neurotoxic aggregating proteins in the brain, have abnormal axonal transport and synaptic transmission issues and have a partial overlap in etiology, including but not limited to a genetic component.

In certain embodiments, the invention covers methods and pharmaceutical compositions of a large group of buntanetap analogs for preventing, treating, inhibiting, reducing, slowing, or delaying mental illnesses in humans. In certain embodiments, the mental illness is autism, attention deficit-hyperactivity disorder, bipolar disorder, major depressive disorder, or schizophrenia.

"Mental illnesses demonstrate abnormal levels of neurotoxic proteins. These neurotoxic proteins cause impairment in axonal transmission and inflammation, similar to what is seen in neurodegenerative diseases. In fact, axonal transport and synaptic transmission are severely impacted in neuropsychiatric disorders and our drug restores axonal transport and synaptic transmission," said Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis. "In Phase 2a trials of Alzheimer's disease and Parkinson's disease, treatment with buntanetap resulted in improved axonal and synaptic function as well as cognitive and functional health. Through its unique ability to inhibit a range of aggregating proteins, we believe that buntanetap has the potential to restore protein homeostasis and delay the advancement of a number of mental illnesses."

Summary of key coverage:

• A method of preventing, treating, inhibiting, reducing, slowing, or delaying the onset of a mental illness such as autism, attention deficit-hyperactivity disorder (ADHD), bipolar disorder, major depressive disorder, or schizophrenia.
• The administered agent will be buntanetap or its analogs used either alone or in combination with an antipsychotic, an antidepressant, or a hallucinogenic agent. 

The Company has been issued patents covering a wide range of neurodegenerative diseases, and this patent, if granted, would represent a significant expansion of Annovis' intellectual property portfolio. Current patents cover neurodegenerative diseases such as Alzheimer's disease (AD), Parkinson's disease (PD), frontotemporal dementia (FTD), chronic traumatic encephalopathy (CTE), acute injuries such as stroke and traumatic brain injury, Amyloid Lateral Sclerosis (ALS), Huntington's disease, and prion diseases.

¹Mental Illness and Amyloid, Brain Sci. 2021, Vol. 11, Issue 1352, P1-14

²Identification of Risk Loci with Shared Effects on Five Major Psychiatric Disorders: a Genome-Wide Analysis, The Lancet, Vol. 381, Issue 9875, P1371-1379, published online Feb. 28, 2013

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. is a clinical-stage, drug platform company developing transformative therapies that treat neurodegenerative disorders such as Alzheimer's disease (AD), Parkinson's disease (PD) and other chronic and acute neurodegenerative diseases. The Company believes that it is the only company developing a drug that inhibits more than one neurotoxic protein, improves the information highway of the nerve cell, known as axonal transport, reduces inflammation and protects nerve cells from dying in chronic and acute neurodegeneration. Annovis conducted two Phase 2 studies: one in AD patients and one in both AD and PD patients. In the AD/PD study, buntanetap showed improvements in cognition and memory in AD as well as body and brain 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 Statements
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words, and include, without limitation, statements regarding the timing, effectiveness, and anticipated results of buntanetap clinical trials. Forward-looking statements are based on Annovis Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Annovis Bio, Inc. undertakes no duty to update such information except as required under applicable law.

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SOURCE Annovis Bio