Annovis Bio Announces Last Patient Last Visit in the Phase III Study of Buntanetap in Parkinson’s Disease
December 05 2023 - 7:30AM
Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform
company developing novel therapies for neurodegenerative diseases
today announced last patient last visit in the phase III study of
its lead candidate buntanetap in patients with early Parkinson’s
disease (PD). Topline data results are expected in January
2024.
"We are pleased to share the completion of our
Parkinson's study which marks a significant step forward in our
ongoing mission to bring new therapies for those affected by this
challenging neurodegenerative disease," said Maria Maccecchini,
Ph.D., Founder, President, and CEO of Annovis. “The study saw a
substantial level of participation, with patients enrolling at a
record pace."
"We extend our appreciation to all participants
and collaborators whose contributions enabled efficient and timely
completion of the study," said Melissa Gaines, Senior Vice
President, Clinical Operations. “Our team now shifts its focus to
diligently cleaning and analyzing the data to meet our goal of
sharing the topline results early next year."
About the Phase III TrialThis
study is a phase III, 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.
Patients were treated with buntanetap (10 mg or 20 mg) or placebo
for 6 months. The study was initiated in August 2022 with a record
pace of full enrollment in just nine months and a total of 616
screened, 523 randomized and 471 completed patients across 67 sites
(43 in the United States and 24 in the European Union).
Screen failure (15%) and drop out (9.9%) rates were below
projections.
About
Buntanetap Buntanetap (formerly known as Posiphen
or ANVS401) attacks neurodegeneration by reducing multiple
neurotoxic proteins, thereby improving synaptic transmission and
axonal transport, which is the information highway of the nerve
cell. Dysfunction of synaptic transmission and axonal transport 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.
About Annovis Bio,
Inc.Headquartered in Berwyn, Pennsylvania, 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
more information on Annovis Bio, please visit the Company's website
www.annovisbio.com and follow us on LinkedIn and Twitter.
Forward-Looking StatementsThis
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.
Investor Contacts:Maria
Maccecchini, Ph.D.maccecchini@annovisbio.com
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