Annovis Bio Announces the Filing of a Groundbreaking Patent
June 27 2023 - 6:30AM
Business Wire
The composition of matter patent is the single most important
patent for any pharmaceutical company developing a new drug
Annovis Bio, Inc. (NYSE: ANVS), a clinical stage drug platform
company developing novel and transformative therapies for
neurodegenerative diseases, announces the creation of a novel
crystalline form of buntanetap (ANVS402), and the filing of a new
composition of matter provisional patent with the U.S. Patent and
Trademark Office.
The patent is groundbreaking because ANVS402 offers significant
advantages over the previous, less structured form, including
better stability, higher purity, and longer half-life, improving
buntanetap’s effectiveness. ANVS402 is covered by a composition of
matter claim as well as multiple claims for chronic and acute
neurodegenerative diseases and for neuropsychiatric
indications.
The composition of matter patent is the single most important
patent for any pharmaceutical company developing a new drug.
Approval of this patent will come with protection of ANVS402 and
all its uses for a 20-year patent term.
“A new 20-year patent term means that we will be able to
continue working on our robust pipeline, developing novel drug
therapies for many of neurodegenerative diseases,” said Maria
Maccecchini, Ph.D., CEO of Annovis.
The mechanism of action, favorable toxicology profile and mode
of administration of Annovis’ drug, position it as a leader among
the current drugs on the market and in development. While those
drugs have shown little efficacy in reversing neurodegenerative
diseases, only slowing progression by attempting to remove just one
neurotoxic protein, buntanetap has been shown to effectively stop
the synthesis of four neurotoxic proteins: Amyloid Beta, Tau, alpha
Synuclein, and TDP43, the culprits behind nerve cell degeneration
and death. Buntanetap early trials have shown its ability to
reverse destructive effects these diseases have on thinking,
memory, movement, and more.
Annovis enters an ecosystem where the only two disease-modified
drugs that exist have shown well-documented, serious side effects,
like amyloid-related imaging abnormalities (ARIA), which can
manifest as brain swelling or bleeding. In contrast, buntanetap has
been well-tolerated with low side effects (no drug-related SAEs, or
serious adverse events) and each AE (adverse event) less than 2
percent in clinical trials. Buntanetap is more easily administered
than its competitors’ (a single pill a day versus intravenous
infusions) and, as a result, Annovis has observed rapid trial
enrollment, with a low dropout rate of 6 percent, and high rates of
patient compliance.
Currently, Annovis is conducting ongoing clinical trials of its
lead drug candidate buntanetap: a phase III study is testing the
medication in early Parkinson’s Disease, and a phase II/III study
is testing the medication in moderate Alzheimer’s Disease. ANVS402
is expected to replace buntanetap in future PD and AD clinical
trials after completion of a bridging study in early 2024. In
addition, the phase III Parkinson’s Disease study recently received
a positive safety review from the Data and Safety Monitoring Board
(DSMB).
“Annovis is extremely excited about the potential of ANVS402 and
its future iterations in the treatment of neurodegenerative
diseases,” said Michael Hoffman, chairman of Annovis.
About Annovis Bio, Inc. Headquartered in Berwyn, Pa.,
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 information about the company’s clinical trials and
patents, visit anovisbio.com, and follow the company on LinkedIn
and Twitter.
Forward-Looking Statements This 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.
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Investor Contact: Laura Feragen Jacobson Strategic Health
laura@jacobsonstrategic.com 267-262-4309
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