CohBar Granted U.S. Patent Covering CB4211 Compositions and Use for Treating Nonalcoholic Steatohepatitis (NASH)
September 08 2021 - 9:00AM
CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company
developing mitochondria based therapeutics to treat chronic
diseases and extend healthy lifespan, today announced the United
States Patent and Trademark Office has granted a patent, U.S. No.
11,111,271, covering CohBar’s lead candidate CB4211 and related
compositions, as well as methods of treatment, including methods of
treating nonalcoholic steatohepatitis (NASH).
"The issuance of this patent is a major
milestone for CohBar, providing protection for CB4211, our lead
clinical asset in the U.S., which recently completed a successful
Phase 1a/1b clinical trial as a potential treatment for NASH and
obesity," said Dr. Joseph Sarret, CEO of CohBar. "We are continuing
to execute on our plan to secure comprehensive intellectual
property protection for CB4211 and other discoveries from our novel
mitochondria based therapeutic technology platform in strategically
important markets."
The term of the new patent extends to at least
2037, not including any patent term extension to which CohBar may
be entitled. Should CB4211 be approved in the United States, the
new patent would be eligible for listing in the FDA Orange
Book.
The new patent further extends CohBar's growing
intellectual property portfolio, which now includes 13 issued
patents and more than 65 filed applications directed to novel
analogs of mitochondrially encoded peptides and methods of treating
a variety of diseases.
About CB4211CB4211, discovered
by CohBar scientists, is a first-in-class mitochondria based
therapeutic (MBT) under development for the treatment of
nonalcoholic steatohepatitis (NASH) and obesity. CB4211 recently
demonstrated positive effects on reducing biomarkers of liver
injury and improving metabolic homeostasis in a Phase 1a/1b
clinical study in obese subjects with nonalcoholic fatty liver
disease (NALFD). CB4211 is a novel and improved analog of MOTS-c, a
naturally occurring mitochondrial derived peptide (MDP). MOTS-c was
discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his
academic collaborators and has been shown to play a significant
role in the regulation of metabolism in animal models. NASH has
been estimated to affect as many as 30 million adults in the U.S.,
and there is currently no approved treatment for the disease.
About CohBar
CohBar (NASDAQ: CWBR) is a clinical stage
biotechnology company focused on the research and development of
mitochondria based therapeutics, an emerging class of drugs for the
treatment of chronic and age-related diseases. Mitochondria based
therapeutics originate from the discovery by CohBar’s founders of a
novel group of naturally occurring peptide sequences within the
mitochondrial genome, some of which have been shown to have the
potential to regulate key processes in multiple systems and organs
in the body. To date, the company has discovered more than 100
mitochondrial derived peptides and generated over 1,000 analogs.
CohBar’s efforts focus on the development of these peptides into
therapeutics that offer the potential to address a broad range of
diseases associated with the underlying impact of mitochondrial
dysfunction. The company’s lead compound, CB4211, which is under
development for the treatment of NASH and obesity, recently
completed a successful Phase 1a/1b clinical trial. In addition,
CohBar has four preclinical programs, the most advanced of which is
CB5138-3, a peptide with broad anti-fibrotic and anti-inflammatory
properties. This program is currently in IND-enabling studies with
the goal of filing an IND and initiating a First-in-Human study in
2022 with an initial indication of idiopathic pulmonary fibrosis.
The company also has a program in ARDS, including COVID-19
associated ARDS, as well as two peptide families with potential
utility in treating various forms of cancer.
For additional company information, please visit
www.cohbar.com.
Forward-Looking Statements
This news release contains forward-looking statements that are
not historical facts within the meaning of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements are based
only on our current beliefs, expectations and assumptions regarding
the future of our business, future plans and strategies,
projections, anticipated events and other future conditions. In
some cases you can identify these statements by forward-looking
words such as “believe,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “could,” “should,” “would,” “project,”
“plan,” “expect,” “goal,” “seek,” “future,” “likely” or the
negative or plural of these words or similar expressions. Examples
of such forward-looking statements include but are not limited to
statements regarding timing and anticipated outcomes of research
and clinical trials for our mitochondria based therapeutic (MBT)
candidates; the ability to provide patent protection for our
CB4211 program; the potential listing of the patent in the FDA’s
Orange Book; expectations regarding the growth of MBTs as a
significant future class of drug products; and statements regarding
anticipated therapeutic properties and potential of our
mitochondrial peptide analogs, MBTs and other potential therapies.
You are cautioned that such statements are not guarantees of future
performance and that actual results or developments may differ
materially from those set forth in these forward-looking
statements. Factors that could cause actual results to differ
materially from these forward-looking statements include: our
ability to successfully advance drug discovery and development
programs, including the delay or termination of ongoing clinical
trials and the timing of announcements and updates relating to our
clinical trials and related data; our possible inability to
mitigate the prevalence and/or persistence of the injection site
reactions, receipt of unfavorable feedback from regulators
regarding the safety or tolerability of CB4211 or the possibility
of other developments affecting the viability of CB4211 or CB5138-3
as a clinical candidate or their commercial potential; results that
are different from earlier data results including less favorable
results that may not support further clinical development; our
ability to raise additional capital when necessary to continue our
operations; our ability to recruit and retain key management and
scientific personnel; the risk that our intellectual property may
not be adequately protected; our ability to establish and maintain
partnerships with corporate and industry partners; and risks
related to the impact on our business of the COVID-19 pandemic or
similar public health crises. Additional assumptions, risks and
uncertainties are described in detail in our registration
statements, reports and other filings with the Securities and
Exchange Commission and applicable Canadian securities regulators,
which are available on our website, and at www.sec.gov or
www.sedar.com. You are cautioned that such statements are not
guarantees of future performance and that our actual results may
differ materially from those set forth in the forward-looking
statements. The forward-looking statements and other information
contained in this news release are made as of the date hereof and
CohBar does not undertake any obligation to update publicly or
revise any forward-looking statements or information, whether as a
result of new information, future events or otherwise, unless so
required by applicable securities laws. Nothing herein shall
constitute an offer to sell or the solicitation of an offer to buy
any securities.
Contacts: Jordyn TaraziDirector of Investor
RelationsCohBar, Inc.(650) 445-4441Jordyn.tarazi@cohbar.com
Media:Nancy ThompsonVorticom,
Inc.(212)532-2208Nancyt@vorticom.com
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