Annovis Bio Announces Plans for a New Phase II Clinical Trial to Treat 68 Parkinson’s and Alzheimer’s Patients
April 30 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, announced
today that the protocol for its Phase 2 clinical study in PD
and AD patients was submitted to the U.S. Food and Drug
Administration (FDA). The Company has received no comments from the
FDA and is therefore able to proceed with the launch of the
clinical trial.
The protocol is a two-part study designed to
treat a combined total of 68 Alzheimer’s and Parkinson’s
patients for one month with Annovis’ 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 Annovis’ drug candidate, ANVS401, might reverse the
toxic cascade and recover normal brain function. As regards AD,
there has been a string of clinical trial failures whose drugs were
based on the belief that sticky brain plaques causes 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.
“We decided to add an Alzheimer’s arm to our
Parkinson’s study because we want to treat patients the exact same
way, monitor them the exact same way, and measure the exact same
biomarkers, transport proteins, inflammatory markers, synaptic and
degenerative markers. Although this is a short study, for safety
purposes we will also measure cognition and function,” commented
Maria Maccecchini, Ph.D., CEO of Annovis Bio. “This study will
allow us to compare neurodegeneration in two different diseases and
show that ANVS 401 works in both neurodegenerative diseases the
same way.”
The clinical trial is expected to take place at 10 sites across
the US. The Company expects to begin recruitment and enrollment in
May, with treatment starting in June. The Company believes the
study will be completed before the end of 2020, but due to the
COVID-19 pandemic, the study’s commencement may be delayed until
later this summer and completion may be delayed until the first
quarter of 2021.
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 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.
Annovis Bio (NYSE:ANVS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Annovis Bio (NYSE:ANVS)
Historical Stock Chart
From Sep 2023 to Sep 2024