Pa., Oct. 11,
2022 /PRNewswire/ -- Annovis Bio, Inc. (NYSE: ANVS)
("Annovis" or the "Company"), a late-stage clinical drug platform
company addressing neurodegenerative diseases, today announced the
publication of Phase 2a clinical study data in The Journal of
Prevention of Alzheimer's Disease.
The published study, titled 'Buntanetap, a Novel
Translational Inhibitor of Multiple Neurotoxic Proteins, Proves to
Be Safe and Promising in Both Alzheimer's and Parkinson's
Patients', evaluated safety, pharmacokinetics, biomarkers, and
efficacy of buntanetap in treating early Alzheimer's Disease (AD)
and Parkinson's Disease (PD) patients. The study demonstrated that
buntanetap was well tolerated, safe and significantly improved
cognition in AD patients and motor function in PD patients.
"Given the short duration of our Phase 2a clinical trial, we are
delighted to see that patients treated with buntanetap had a
statistically significant improvement in cognition and
function," said Maria L. Maccecchini, Ph.D., Founder,
President, and CEO of Annovis Bio. "We believe that the
effects on cognition and motor function after such a short
treatment are due to buntanetap's ability to restore neuronal
function through the improvement of axonal integrity, synaptic
transmission, and reduction of inflammation."
Cheng Fang, Ph.D., Senior Vice President of Research &
Development at Annovis Bio, added: "These fast-acting effects
suggest that buntanetap can function as a symptomatic drug to give
patients quick relief of their neurological symptoms. Based on
animal studies, we also believe that buntanetap can function as a
disease-modifying drug in both AD and PD patients as it will
continue to reduce the levels of neurotoxic aggregating proteins
and preserve neuronal integrity. We are testing this hypothesis
further in our late-stage clinical trials with larger patient
populations and longer treatment times."
Annovis has begun dosing patients in the Company's Phase 3
clinical trial evaluating buntanetap in early PD. The Phase 3 trial
is a randomized, double-blind, placebo-controlled trial
investigating the efficacy, safety, and tolerability of buntanetap.
The trial will enroll a total of 450 early PD patients to be
treated with 10mg buntanetap, 20mg buntanetap or a placebo, on top
of their standard of care for six months.
In early October, the U.S. Food and Drug Administration
authorized a Phase 2/3 clinical study of buntanetap in moderate AD.
The Phase 2/3 study is a randomized, double-blind,
placebo-controlled trial investigating the efficacy, safety, and
tolerability of buntanetap in moderate AD patients. The trial will
enroll a total of 320 AD patients to be treated with 7.5mg
buntanetap, 15mg buntanetap, 30mg buntanetap or a placebo, on top
of their standard of care for three months.
Buntanetap (previously known as ANVS401 or Posiphen) is an oral
translational inhibitor of neurotoxic aggregating proteins
(TINAPs), which mode of action leads to a lower level of neurotoxic
proteins and consequently less toxicity in the brain. In a Phase 2a
clinical trial in AD and PD patients, buntanetap was shown to be
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. Additionally, exploratory
endpoints were also met, as treatment with buntanetap resulted in
statistically significant improvement in motor function in PD
patients and cognition in AD patients. Presently buntanetap is
being studied in a phase 3 early PD study and will enter a phase
2/3 study in AD patients later in the year.
About Annovis Bio,
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.
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:
Russo Partners, LLC
View original content to download
SOURCE Annovis Bio