BERWYN,
Pa., Oct. 6,
2022 /PRNewswire/ -- Annovis Bio, Inc. (NYSE: ANVS)
("Annovis" or the "Company"), a late-stage clinical drug platform
company addressing neurodegenerative diseases, announced today that
the U.S. Food and Drug Administration (FDA) has authorized the
Phase 2/3 clinical study of buntanetap in moderate Alzheimer's
Disease (AD).
Following the submission of the Phase 2a clinical safety data
and the chronic toxicology data in animals, the Company requested
approval to further pursue the development of buntanetap in AD. The
FDA approved the Company's development plan, study protocol and
authorized the initiation of the Phase 2/3 clinical study of
buntanetap in AD.
"We are very pleased with the clinical progress of buntanetap,"
said Maria L. Maccecchini, Ph.D., Founder, President, and CEO of
Annovis Bio. "In a Phase 2a clinical trial in AD and PD, treatment
with buntanetap resulted in statistically significant improvement
in motor function in PD patients and cognition in AD patients. With
this promising data, we have progressed buntanetap into a Phase 3
trial for the treatment of early PD, and now with FDA
authorization, into a Phase 2/3 trial for the treatment of moderate
AD. We are on a clinical development pathway to bring forward a
promising treatment for both far reaching neurodegenerative
indications."
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 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,
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.
Media and Investor Contact:
Nic Johnson
Russo Partners, LLC
(303) 482-6405
nic.johnson@russopartnersllc.com
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SOURCE Annovis Bio
