BERWYN,
Pa., Aug. 24, 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 first patient in the Phase 3
clinical trial evaluating buntanetap in early Parkinson's Disease
(PD) has been dosed.
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.
Movement Disorder Society-Sponsored Revision of the Unified
Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and III will
be used as primary endpoints, while total MDS-UPDRS and Participant
Global Impression of Change will be secondary endpoints. In
addition, Wechsler Adult Intelligence Scale, plasma biomarkers and
Mini-Mental State Examination will be evaluated as exploratory
endpoints.
The Company previously reported results from its Phase 2a study
of buntanetap in PD patients, which were treated with 5mg, 10mg,
20mg, 40mg or 80mg daily with no clinically significant adverse
events. Additionally, treatment with buntanetap resulted in
statistically significant improvement in motor function and its
pharmacokinetics were found to be in line with levels measured
earlier in humans, meeting both the primary and secondary
endpoints.
Maria L. Maccecchini, Ph.D., Founder, President, and CEO
of Annovis Bio said: "Buntanetap has shown promising
preliminary safety data in all clinical work to date. Just as
encouraging is the significant improvement in speed of movement,
motor function and cognitive function observed in early to moderate
PD patients treated with buntanetap in the Phase 2a trial. Now, as
we officially advance buntanetap into a Phase 3 trial, with a
longer treatment duration and a dose range shown to be efficacious
in early studies, we are one step closer to delivering a solution
that can transform the lives of patients with Parkinson's Disease."
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,
buntanetap was shown to reduce biomarkers associated with AD or PD,
it was well-tolerated and safe, and its pharmacokinetics were found
to be in line with levels measured earlier in humans, meeting
primary, secondary and exploratory 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
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SOURCE Annovis Bio