CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company
developing mitochondria based therapeutics to treat chronic
diseases and extend healthy lifespan, today announced the selection
of CB5138-3 as its lead candidate for advancement into IND-enabling
activities. CB5138-3 is a CB5138 Analog, a novel class of molecules
derived from a natural, mitochondrially encoded peptide source
discovered by CohBar, with potential for treatment of Idiopathic
Pulmonary Fibrosis (IPF) and other fibrotic diseases. IPF is a
chronic, progressive, debilitating and usually fatal interstitial
lung disease that affects approximately 100,000 people in the U.S.
This orphan disease results in fibrotic scarring of the lungs.
“Nominating our second clinical candidate is an
exciting milestone for CohBar and provides additional confirmation
of the potential of our novel discovery platform for mitochondria
based therapeutics,” stated Steven Engle, CohBar’s Chief Executive
Officer. “Our positive preclinical data in models of IPF support
the further development of CB5138-3 as a potential antifibrotic and
anti-inflammatory therapeutic for IPF, which remains an unmet
medical need with few treatment options. Drugs currently approved
for IPF can slow the progression of disease but can also cause
significant side effects that limit their use. We look forward to
the possibility of providing a new treatment option for this
devastating disease and exploring the therapeutic potential of
CB5138-3 as a treatment of other fibrotic diseases, including other
interstitial lung diseases. Fibrotic diseases can affect any organ
and are collectively responsible for 45% of deaths in the developed
world.”
In the therapeutic mouse model of IPF, multiple
CB5138 Analogs demonstrated positive effects on all study outcomes,
including reduction of fibrosis, inflammation, and collagen
deposition. CohBar also showed enhanced effects for a CB5138 Analog
in combination with the standard of care nintedanib, such as
greater reduction in fibrosis, inflammation, collagen, and
pro-inflammatory cytokines compared to nintedanib alone. CohBar has
now completed candidate screening activities and selected CB5138-3
as the lead CB5138 Analog for further development based on its
preclinical efficacy data, preliminary safety profile, and
drug-like properties.
CohBar will move forward with IND-enabling
activities for CB5138-3 with the goal of initiating clinical
studies in 2022. In addition, the company is continuing to evaluate
the efficacy of the CB5138 Analogs in models of other fibrotic
diseases such as NASH, systemic sclerosis, and kidney fibrosis.
Fibrosis can occur in the lungs, brain, liver, heart, and other
organs.
About CB5138 Analogs
CB5138 Analog peptides are modified analogs of a
natural peptide sequence encoded in mitochondrial DNA. Data on the
efficacy of CB5138 Analog peptides in preclinical models of IPF
were presented at the American Thoracic Society Virtual Annual
Meeting in August 2020. In co-cultures of human lung cells,
CB5138-1 decreased the expression of key fibrosis biomarkers,
including alpha smooth muscle actin (αSMA), and collagen types I
and III. CB5138-1 also decreased the transformation of healthy lung
cells into fibrotic cells after induction by TGF-beta1, resulting
in reduced production of the fibrotic components αSMA and
pro-collagen I alpha 1. In vivo, CB5138-1 decreased lung fibrosis
and inflammation in both the prophylactic mouse model of IPF,
initiating treatment with the peptide immediately after fibrosis
induction by bleomycin, and in the therapeutic mouse model of IPF,
starting peptide treatment one week after induction. In addition,
using the more exacting therapeutic model of IPF, two new analogs
of CB5138 (CB5138-2 and CB5138-3) significantly reduced lung
fibrosis assessed by the Ashcroft Score, reduced inflammation, and
decreased fibrosis-related changes in lung weight, collagen
deposition in lung tissue, and collagen secretion into lung
fluid.
About IPF & Fibrotic
Diseases
Idiopathic Pulmonary Fibrosis (IPF) is a
chronic, progressive, debilitating and usually fatal interstitial
lung disease that affects approximately 100,000 people in the U.S.
This orphan disease results in fibrotic scarring of the lungs.
While there are two approved treatments that can help slow the
progression of IPF, there is currently no treatment that can stop
or reverse the scarring of the lung. Side effects of current
approved therapies include gastrointestinal and skin effects.
Early detection of disease is key to slowing
progression, while most patients have a three-to-five-year life
expectancy. IPF is one example of fibrotic disease. Fibrotic
diseases can affect any organ, including liver, kidney, heart,
intestines, bone, etc., which together account for 45% of deaths in
the developed world.
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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