Annovis Bio Provides Third Quarter 2020 and Year-to-Date Business Highlights
October 15 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
its business highlights for the third quarter ended September 30,
2020.
“We are thrilled with the strong progress we
have made since our IPO in January of this year and the continued
productivity despite the COVID-19 pandemic,” said Maria
Maccecchini, Ph.D., Founder and Chief Executive Officer. “A major
milestone in the third quarter was the start of our new phase 2a
study in Alzheimer’s and Parkinson’s patients, which we expect to
report preliminary data from in the first quarter of 2021. Based on
what we know today, we believe that our breakthrough platform
technology could result in medicines that can change the
world.”
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
Bio has developed a new approach to treat AD as well as PD by
attacking multiple neurotoxic proteins simultaneously. In six
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.
Third Quarter and Year-to-Date 2020 Business
Highlights
- Started a Phase 2a clinical
study in patients with mild to moderate AD and PD. This
Phase 2a trial is a one-month study that will treat 14 AD and
14 PD patients at up to 15 sites across the US. The study is
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. 12 markers will be measured in spinal fluid
as well as in plasma. Initial data from this trial is expected in
early 2021. This study will be followed by a dose response study in
40 PD patients, and the Company expects the final readout by late
summer 2021.
- Restarted the AD study that
was put on hold due to Covid-19. This Phase 2a trial of
the Company’s lead compound, ANVS401, is a one-month study in 24 AD
patients conducted in collaboration with the Alzheimer Disease
Cooperative Study at six sites in the US. Prior to suspension of
enrollment, 14 patients had been enrolled and treated in this
trial. Data from this trial is expected in 2021.
- Completed treatment of
animals in the Company’s chronic
toxicology study funded by the NIH. The Company
reported that rats treated with ANVS401 for six months showed no
significant negative side effects. The study has completed the
treatment of dogs for nine months and the Company is awaiting the
analysis of the results. Successful completion of the chronic
toxicology study will enable the Company to conduct long-term
studies of ANVS401 in humans.
- Completed work on
the mechanism of action for ANVS401 using
proteomics, microscale thermophoresis and
bio-layer interferometry. As anticipated, research
showed that the mechanism of action for ANVS401 is specific for
neurotoxic aggregating proteins.
- Started collaboration to
further elucidate the mechanism of action for
ANVS401 by binding, crystallography, and
cryo-electron microscopy. This work shows the actual
interactions and complex formations between iron regulatory protein
1 and the atypical iron response element of neurotoxic aggregating
protein mRNAs by different visualization methodologies.
- Published
three scientific papers related to ANVS401. In September,
the Company announced the publication of a manuscript
in Alzheimer's & Dementia: The Journal of the Alzheimer's
Association, “Targeting increased levels of APP in Down syndrome:
Posiphen-mediated reductions in APP and its products reverse
endosomal phenotypes in the Ts65Dn mouse model,” which demonstrated
improved axonal transport in nerve cells and brain of down syndrome
mice, an animal model of AD. In April, the Company announced the
publication of data in two double-blind, placebo-controlled animal
studies – one in AD mice and one in PD mice -demonstrating
preclinical efficacy of ANVS401 in both diseases. The AD study was
published in Alzheimer’s & Dementia: Translational Research
& Clinical Interventions and the PD study was published in the
American Journal of Neurodegenerative Disease.
- Granted two patents and
filed five additional patents. In March, the European
Patent Office granted the Company’s patent (EP 2683242) for a
method of treating Alzheimer’s disease in humans by administering
ANVS401. Previously, the Company announced it was issued a patent
(US 10,383,851) for a method of treating Parkinson’s disease, Lewy
body dementia and other Lewy body diseases in humans by
administering ANVS401. Four divisional patents were also filed
related to tauopathies (frontotemporal dementia, chronic traumatic
encephalopathy), amyotrophic lateral sclerosis, Huntington’s
disease, and prion diseases. Finally, a provisional patent
application concerning a method of inhibiting, preventing, or
treating neurological injuries due to viral, bacterial, fungal,
protozoan, or parasitic infections in humans and in animals via
administration of ANVS401 or related compounds was filed with the
U.S. Patent & Trademark Office.
About Annovis BioHeadquartered 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 StatementsStatements 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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