Annovis Bio Begins Treatment of First Patients in its Phase 2a Alzheimer’s and Parkinson’s Trial
September 01 2020 - 6:45AM
Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug
platform company addressing Alzheimer’s disease (AD), Parkinson’s
disease (PD) and other neurodegenerative diseases, today announced
dosing of the first three patients in its new Phase 2a clinical
trial targeting early AD and PD patients.
The two-part study, which received IRB approval
in July 2020, is designed to treat a combined total of 28 AD and PD
patients for four weeks with Annovis' lead compound, ANVS401. The
study compares in both patient populations how nerve cells die by
measuring all the steps in the toxic cascade leading to nerve cell
death and how ANVS401 might reverse the toxic cascade and recover
normal brain function. In addition to target and pathway
engagement, the Phase 2a study also examines safety and
tolerability as well as the effect of ANVS401 on motor and
non-motor symptoms in early PD patients and the effect on memory
and cognitive function in early AD subjects. Initial data from this
trial is expected in early 2021. This study will be followed by a
dose response study in 40 PD patients with final data readout
expected by late summer 2021.
“Beginning treatment in our second Phase 2a
study is a major milestone for Annovis,” commented Maria
Maccecchini, Ph.D., CEO of Annovis Bio. “This brings us one step
closer to evaluating whether our approach may translate into a
novel treatment option for patients suffering from a range of
neurodegenerative diseases.”
Annovis Bio is following all FDA recommendations
and taking appropriate precautions regarding COVID-19 and has
selected the 15 sites for the study to be geographically dispersed
throughout the U.S. The Company is initially targeting recruitment
at sites in areas where COVID-19 is less rampant, while sites in
high COVID-19 areas remain closed.
“While COVID-19 has previously delayed trials
for most biopharma companies, including the start of this trial,
having a diverse mix of study sites should afford us the
opportunity to maintain recruitment and treatment schedules moving
forward,” added Dr. Maccecchini.
There has been a string of clinical trial
failures for drugs based on the belief that sticky brain plaques
cause AD. With 500 failed drugs based on that hypothesis, Annovis
has developed a new approach to treat AD as well as PD by attacking
multiple neurotoxic proteins simultaneously. In two animal models,
ANVS401 reduced neurotoxic proteins, improved axonal transport,
lowered inflammation, and restored healthy nerve cells in both AD
and PD. Based on publicly available data, no other drug has
been shown in animal studies to impede the whole toxic cascade and
show preclinical efficacy in both AD and
PD.
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. AD and PD
significantly impact quality of life for patients and their
families.
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 have commenced a second Phase 2a study in AD and 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, including that
clinical trials may be delayed. 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, CEORedChip Companies
Inc.407-491-4498Dave@redchip.com
SOURCE: Annovis Bio, Inc.
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