BERWYN,
Pa., Sept. 8, 2022 /PRNewswire/ -- Annovis Bio,
Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage
clinical drug platform company addressing neurodegenerative
diseases, today released the following letter to stockholders from
its Chief Executive Officer Dr. Maria
Maccecchini.
Dear Fellow Stockholder,
Over the years we have been talking about the potential of
buntanetap to treat more than Alzheimer's disease. In cell models,
animal models and human clinical studies, we have seen that
buntanetap works in numerous acute and chronic neurodegenerative
conditions. I would like to take this opportunity to explain how
one drug can be so broadly applicable.
Buntenatap works by inhibiting specific neurotoxic proteins such
as amyloid precursor protein (APP), Tau, alpha-synuclein (αSYN),
TAR DNA binding protein 43 (TDP-43), huntingtin (HTT) and prion
protein. These proteins have normal functions but in their
neurotoxic aggregating form, they impair axonal transport, slow
synaptic transmission, cause inflammation, and ultimately, kill
nerve cells, resulting in the loss of affected function in various
neurodegenerative conditions.
The overexpression and aggregation of these proteins is caused
by elevated levels of iron in the nerve cell. The mRNAs of
neurotoxic aggregating proteins contain an iron response element
(IRE) which binds to an iron regulatory protein called IRP1. At
normal iron levels, translation occurs at appropriate physiological
levels. When iron flows into the cell, the mRNAs are released and
translated at higher rates by the ribosome. When massive iron flows
in, the mRNAs remain unbound for as long as the iron is high and
the proteins for these neurotoxic aggregating proteins are
overexpressed. In this high iron situation, buntanetap binds to the
atypical IRE-IRP1 complex and prevents the mRNA from being released
and, therefore, from being translated and overexpressed.
Buntanetap is able to inhibit the translation of multiple
neurotoxic proteins through this mechanism of action, and as a
result has the potential to treat numerous acute and chronic
neurodegenerative conditions that share this pathway. In mouse or
rat models of Alzheimer's, Parkinson's, stroke, frontotemporal
dementia, traumatic brain injury, glaucoma, and Down Syndrome,
buntanetap has been shown to normalize the levels of these
neurotoxic proteins and to restore function.
Most importantly, this has been demonstrated in human clinical
trials. In our recent Phase 2 clinical trial in Alzheimer's disease
and Parkinson's disease, treatment with buntanetap resulted in
reduction of aggregating proteins and statistically significant
improvement in motor function in Parkinson's disease patients and
cognition in Alzheimer's disease patients.
FUNCTION
|
TEST
|
SUBJECT
|
ANIMALS
|
|
|
Memory,
learning
|
Mazes
|
AD mice, DS mice,
stroke mice, TBI rats
|
Movement
|
Colonic motility, grip
strength
|
PD mice, tau
mice
|
Vision
|
Sight
|
Glaucoma
rats
|
Infections
|
Cell death
|
P. Gingivalis mice,
Covid mice
|
HUMANS
|
|
|
Cognition, memory,
learning
|
ADAScog11
|
Early AD
patients
|
Attention, thinking
speed
|
WAIS coding
|
Early AD
patients
|
Movement,
coordination
|
MDS-UPDRS
|
Early PD
patients
|
Movement
speed
|
WAIS coding
|
Early PD
patients
|
|
Table 1: Summary of
all animal and human study data.
|
We look forward to unlocking the full potential of buntanetap
and addressing unmet needs across a range of acute and chronic
neurological conditions.
Maria L. Maccecchini, Ph.D.,
Founder, President, CEO and Executive Board Member
About Buntanetap
Buntanetap (previously known as ANVS401 or Posiphen) is an oral
translational inhibitor of neurotoxic aggregating proteins
(TINAPs), which mode of action leads to lower levels of neurotoxic
proteins and consequently less toxicity in the brain. In a Phase 2a
clinical trial in AD and PD patients, treatment with buntanetap
resulted in statistically significant improvement in motor function
in PD patients and cognition in AD patients. Additionally, the drug
was well-tolerated and safe, and its pharmacokinetics were found to
be in line with levels measured earlier in humans, meeting both the
primary and secondary endpoints.
About Annovis Bio, Inc.
Headquartered in Berwyn,
Pennsylvania, Annovis Bio, Inc. is a late-stage clinical
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.
Media and Investor Contact:
Nic Johnson
Russo Partners, LLC
(303) 482-6405
nic.johnson@russopartnersllc.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/annovis-bios-ceo-maria-maccecchini-issues-letter-to-stockholders-301620142.html
SOURCE Annovis Bio