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."
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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,
2Identification of Risk Loci with Shared Effects on Five Major Psychiatric Disorders: a Genome-Wide Analysis,
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.
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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
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