BERWYN,
Pa., June 8, 2023 /PRNewswire/ -- Annovis Bio,
Inc. (NYSE: ANVS), a clinical-stage drug platform company
addressing neurodegenerative diseases such as Alzheimer's (AD) and
Parkinson's disease (PD) and developing novel and transformative
therapies, announced that its PD phase III study of its lead
compound buntanetap has reached full enrollment in a record nine
months after it began.
Since the first patient was dosed in late August 2022, over 640 patients were screened and
a total of 520 patients enrolled in record time with 67 sites (43
in the United States and 24 in the
European Union).
The phase III trial is a randomized, double-blind,
placebo-controlled trial investigating the efficacy, safety, and
tolerability of buntanetap for early PD patients on top of their
standard of care. Buntanetap (formerly known as Posiphen or
ANVS401) attacks neurodegeneration by reducing multiple neurotoxic
proteins, therefore improving synaptic transmission and axonal
transport, the information highway of the nerve cell, which has
been shown to be the cause of nerve cell degeneration and
ultimately death. Unlike other PD drugs in development which
attempt to remove only one toxic protein, buntanetap inhibits
several toxic proteins before they can form, thereby preventing the
formation of all the major neurotoxic proteins responsible for
PD and AD.
By lowering levels of neurotoxic proteins, buntanetap improves
axonal transport, lowers inflammation, fosters the health of nerve
cells, and improves motor and cognitive dysfunction.
The record enrollment and low drop-out rate are believed to be
due to several factors: In phase I/II the drug showed improvements
in body and motor function, it requires taking only one pill a day,
and it is safe and well tolerated. The study is expected to
conclude in November with top-line assessment data available by the
end of the year.
"The Parkinson's community is extremely well-informed and
connected," said Annovis' founder, president and CEO, Maria Maccecchini, Ph.D. ("Dr. Maria"). "When
they learned of our innovative and patient-focused approach showing
early therapeutic potential they wanted to be involved in making an
impact." The ramifications of such drug therapy could be
transformative for all neurodegenerative diseases, according to Dr.
Maria.
About Annovis Bio, Inc.
Headquartered in Berwyn, Pa., Annovis Bio, Inc.is a
clinical-stage, drug platform company addressing neurodegeneration,
such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and
other chronic neurodegenerative diseases. It is believed to be the
only company developing a drug for both AD and PD designed to
inhibit more than one neurotoxic protein to restore axonal and
synaptic activity. By improving brain function, the company's goal
is to treat memory loss and dementia associated with AD as well as
body and brain dysfunction associated with PD. For information
about the company's clinical trials and patents, visit
anovisbio.com, and follow the company on LinkedIn and
Twitter.
Forward-Looking Statements
This press release contains
"forward-looking" statements within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. All statements other
than statements of historical fact are statements that could be
deemed forward-looking statements. The Company advises caution in
reliance on forward-looking statements. Forward-looking statements
include, without limitation, the Company's plans related to
clinical trials. These statements involve known and unknown risks,
uncertainties and other factors that may cause actual results to
differ materially from those implied by forward-looking statements,
including regarding patient enrollment, the effectiveness of
Buntanetap and the timing, effectiveness, and anticipated results
of the Company's clinical trials evaluating the efficacy, safety
and tolerability of buntanetap. See also additional risk factors
set forth in the Company's periodic filings with the SEC,
including, but not limited to, those risks and uncertainties listed
in the section entitled "Risk Factors," in the Company's Annual
Report on Form 10-K and Quarterly Reports on Form 10-Q filed with
the SEC. All forward-looking statements in this press release are
based on information available to the Company as of the date of
this filing. The Company expressly disclaims any obligation to
update or alter its forward-looking statements, whether as a result
of new information, future events or otherwise, except as required
by applicable law.
Communications Contacts:
Laura Feragen
Jacobson Strategic Health
laura@jacobsonstrategic.com
267-262-4309
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SOURCE Annovis Bio
