MENLO PARK, Calif., July 12, 2018 (GLOBE NEWSWIRE) -- 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, COO
CohBar, Inc.
(650) 446-7888
jon.stern@cohbar.com
