CohBar Completes Last Subject Visit in the Phase 1b Clinical Trial for CB4211 Under Development for NASH and Obesity
April 21 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 that the last
subject has completed their final visit in the Phase 1b stage of
the CB4211 clinical study for nonalcoholic steatohepatitis (NASH)
and obesity. The company currently expects to release topline data
in early July 2021.
The Phase 1b study is a randomized, double-blind,
placebo-controlled evaluation of one dose level of CB4211 given
once a day for four weeks in obese subjects with non-alcoholic
fatty liver disease (NAFLD). The primary endpoints are safety and
tolerability, with a secondary endpoint of pharmacokinetics, and
exploratory endpoints of changes in liver fat, body weight, and
biomarkers relevant to NASH, obesity, and metabolic disease.
Subjects were required to have a minimum of 10% liver fat at
enrollment, and to stay in the clinical study unit during the four
weeks of treatment.
“We would like to thank CohBar’s clinical collaborators, staff,
and clinical participants for their commitment to completing this
study during the ongoing pandemic,” stated Steven Engle, Chief
Executive Officer. “NASH continues to be an emerging epidemic
affecting millions of people worldwide with no approved drug
therapies.”
CB4211 is the first mitochondria based therapeutic to enter
clinical testing. Mitochondria based therapeutics are an emerging
class of drugs based on novel analogs of peptide sequences
discovered by CohBar scientists in 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.
About CB4211
CB4211 is a first-in-class mitochondria based
therapeutic (MBT) that has demonstrated significant therapeutic
potential in preclinical models of nonalcoholic steatohepatitis
(NASH) and obesity. CB4211 is a novel and improved analog of
MOTS-c, a naturally occurring mitochondrial derived peptide (MDP),
which 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. 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, is in the Phase 1b stage of a
Phase 1a/1b clinical trial for NASH and obesity. In addition,
CohBar has four preclinical programs: CB5138 Analogs for
fibrotic diseases, CB5064 Analogs for COVID-19 associated
ARDS, CB5046 Analogs for CXCR4-related cancer and orphan diseases,
and MBT3 Analogs for cancer immunotherapy.
For additional company information, please visit
www.cohbar.com.
Forward-Looking Statements
This news release contains forward-looking statements which 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 and statements regarding timing and anticipated
therapeutic properties and potential of CB5138-3. 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, research and development programs,
including the delay or termination of ongoing clinical trials; 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
as a clinical candidate or its commercial potential; results that
are different from earlier data results including less favorable
than and 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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