CohBar Initiates Clinical Study with First-in-human Dosing of CB4211, a Novel Mitochondria Based Therapeutic for the Treatmen...
July 12 2018 - 9:00AM
CohBar, Inc. (NASDAQ:CWBR), a clinical stage biotechnology company
developing mitochondria based therapeutics (MBTs) to treat
age-related diseases, today announced that it has initiated a Phase
1a/1b safety and biomarker study of CB4211, its lead MBT candidate
under development as a potential treatment for non-alcoholic
steatohepatitis (NASH) and obesity. CB4211 is the first
mitochondria based therapeutic to enter clinical testing.
“The successful completion of our preclinical studies, filing
and clearance of the IND, and initiation of this clinical study
represent major milestones for the company, as we begin to validate
the therapeutic potential of peptides encoded in the mitochondrial
genome,” said Kenneth C. Cundy, CohBar CSO. “The peptide showed
impressive efficacy in preclinical models, and this clinical study
is designed to assess safety, as well as to provide an early
indication of the therapeutic potential of CB4211 in the setting of
NASH and obesity.”
The double-blind, placebo-controlled clinical study will
initially assess the safety, tolerability, and pharmacokinetics of
CB4211 following single and multiple-ascending doses in healthy
subjects. The final Phase 1b stage of the study will be an
assessment of safety, tolerability, and activity in obese subjects
with non-alcoholic fatty liver diseases (NAFLD). Assessments will
include changes in liver fat assessed by MRI-PDFF, body weight, and
biomarkers relevant to NASH and obesity.
About CB4211
CB4211 is a first-in-class mitochondria based therapeutic 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. Data were presented at the 2018 American Diabetes
Association meeting providing in vitro evidence that CB4211
inhibits adipocyte lipolysis, a process that is foundational in the
development of liver steatosis, through an insulin-dependent
mechanism. These data provide a potential mechanistic explanation
for previous observations in vivo, including efficacy of CB4211 in
animal models of NASH, and anti-steatotic effects on livers of mice
on a high fat diet, where a corresponding reduction in circulating
fat and biomarkers of liver damage was also observed. The
activity of CB4211 appears to be specific to sensitizing insulin
action on the insulin receptor. NASH has been estimated to affect
as many as 12% of adults in the U.S. and there is currently no
approved treatment for the disease.
About CohBar
CohBar is a clinical stage biotechnology company focused on the
research and development of mitochondria based therapeutics (MBTs),
an emerging class of drugs for the treatment of age-related
diseases. MBTs originate from the discovery by CohBar’s founders of
a novel group of peptides within the mitochondrial genome which
regulate metabolism and cell death, and whose biological activity
declines with age. CohBar’s efforts focus on the development of
these mitochondrial-derived peptides (MDPs) into clinically
relevant MBTs that offer the potential to address a broad range of
age-related diseases with underlying metabolic dysfunction,
including nonalcoholic steatohepatitis (NASH), obesity, Type 2
diabetes, cancer, and cardiovascular and neurodegenerative
diseases. To date, the company and its founders have discovered
more than 100 MDPs. For additional company information, please
visit www.cohbar.com.
Forward-Looking Statements
This news release contains forward-looking statements
(statements which are not historical facts) within the meaning of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include CohBar’s plans and expectations
for its lead CB4211 drug candidate program, including statements
regarding the efficacy, mechanism of action and therapeutic and
commercial potential of CB4211 and other mitochondria based
therapeutics. Forward-looking statements are based on current
expectations, projections and interpretations that involve a number
of risks and uncertainties that could cause actual results to
differ materially from those anticipated by CohBar. These include
uncertainties inherent in research and development, such as the
possible inability to complete clinical studies as anticipated, the
possibility of unfavorable study results, including unfavorable new
data or additional analyses of existing data; risks associated with
initial data, including the risk that results of clinical studies
may be different from (including less favorable than) those
suggested by earlier data results and may not support further
clinical development or which otherwise affect the viability or
commercial potential of CB4211 or other candidate
programs. 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 laws.
Investor and Media Contact: Jon Stern,
COOCohBar, Inc. (650) 446-7888 jon.stern@cohbar.com
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