Annovis Bio Publishes Results of Alzheimer’s and Parkinson’s Animal Studies
23 April 2020 - 9:00PM
Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug
platform company addressing Alzheimer’s disease, Parkinson’s
disease and other neurodegenerative diseases, published data from
its two double-blind, placebo controlled animal studies in
Alzheimer’s disease (AD) and Parkinson’s disease (PD) demonstrating
in both diseases preclinical efficacy of ANVS401, the company’s
lead compound.
“No drug to date has shown efficacy in two
totally different animal models of neurodegeneration,” commented
Maria Maccecchini, Ph.D., CEO of Annovis Bio. “In our AD animal
studies, ANVS401 was shown to lower amyloid precursor protein (APP)
and all its fragments, and animals fully recovered memory,
learning, fear conditioning, and brain function. In our PD animal
studies, ANVS401 lowered levels of α-synuclein and normalized gut
motility in two transgenic animal models of PD. Together, these
data are very exciting and provide strong support for moving
forward in our development of ANVS401 for both AD and PD.”
The Alzheimer’s study, conducted by Professor
Ottavio Arancio at Columbia University and published in Alzheimer’s
& Dementia: Translational Research & Clinical
Interventions, is the first study demonstrating the therapeutic
efficacy in animals of inhibiting the translation of APP and its
fragments in an AD model. Translational inhibition of APP by
ANVS401 has been shown to reduce APP and its fragments in cell
culture, animal models, and mildly cognitively impaired patients,
making it a promising drug candidate for the treatment of AD.
The study used a mouse model of AD to examine
ANVS401’s efficacy, pharmacodynamics, and pharmacokinetics. In the
study, ANVS401 treatment normalized impairments in spatial working
memory, contextual fear learning, and synaptic function in
APP/presenilin-1 mice, without affecting their visual activity,
motor skills, or motivation and without affecting wild-type mice.
ANVS401 had a prolonged effect in reducing APP and all related
peptides for at least nine hours after the last dose. Its
concentration was higher in the brain than in plasma, and the most
abundant metabolite was N8-NorPosiphen.
The Parkinson’s study, conducted by Professor
Robert Nussbaum at University of California San Francisco and
published in the American Journal of Neurodegenerative Disease, is
the first study showing the preclinical efficacy of ANVS401 in
improving the colonic motility in mouse models of gastrointestinal
dysfunction in early PD. This result demonstrates the ability of
ANVS401 to reach the nervous system, and its mechanism of action,
the translational inhibition of α-synuclein expression, supporting
further development of ANVS401 as a drug for the treatment of
PD.
The study used two α-synuclein transgenic mouse
models to investigate the efficacy of ANVS401 in reversing the
gastrointestinal dysfunction, showing that ANVS401 normalizes the
colonic motility of both transgenic mouse models, while not
affecting the Whole Gut Transit Time (WGTT). Pharmacokinetics
studies revealed that ANVS401 is more abundant in the brain than in
blood, in agreement with its lipophilicity, and the main metabolite
is N8-NorPosiphen, a molecule with similar properties as ANVS401.
The brain levels of ANVS401 necessary to effect optimal function
were calculated in both studies and compared with efficacious brain
levels from previous studies, showing that a 150 nM concentration
of ANVS401 in the brain is sufficient for functional efficacy.
The PD study was funded by the Michael J. Fox
Foundation.
PD is the second most common neurodegenerative
disease after AD and affects the central, peripheral, and enteric
nervous systems. Gastrointestinal dysfunction is a particularly
common non-motor abnormality in PD, documented in over 80% of
patients.
PD affects an estimated one million people in
the U.S. and as many as 10 million globally. An estimated 5.8
million people in the U.S. have AD and there are approximately 44
million people worldwide living with the disease.
About Annovis Bio
Headquartered in Berwyn, Pennsylvania, Annovis
Bio, Inc. (Annovis) is a clinical-stage, drug platform company
addressing neurodegeneration, such as Alzheimer’s disease (AD),
Parkinson’s disease (PD) and Alzheimer’s in Down Syndrome (AD-DS).
We believe that we are the only company developing a drug for AD,
PD and AD-DS that inhibits more than one neurotoxic protein and,
thereby, improves the information highway of the nerve cell, known
as axonal transport. When this information flow is impaired, the
nerve cell gets sick and dies. We expect our treatment to improve
memory loss and dementia associated with AD and AD-DS, as well as
body and brain function in PD. We have an ongoing Phase 2a study in
AD patients and plan to commence a second Phase 2a study in PD
patients. For more information on Annovis, please visit the
company’s website: www.annovisbio.com.
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 ANVS401 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, 2019 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.
Investor Relations:
Dave Gentry, CEO RedChip Companies Inc.
407-491-4498 Dave@redchip.com
SOURCE: Annovis Bio Inc.
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