CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company
developing mitochondria based therapeutics to treat chronic
diseases and extend healthy lifespan, today announced topline
results from the multi-center, randomized, double-blind,
placebo-controlled Phase 1a/1b clinical study of CB4211, under
development for nonalcoholic steatohepatitis (NASH) and obesity.
The study met its primary endpoint showing that CB4211 was
well-tolerated and appeared safe with no serious adverse events.
Evaluation of the exploratory pharmacodynamic endpoints from the
Phase 1b stage of the study comparing CB4211 to placebo
demonstrated robust and significant reductions in key biomarkers of
liver damage, ALT and AST, a significant decrease in glucose
levels, and a trend towards lower body weight after four weeks of
treatment. Both the CB4211 and placebo groups had substantial
reductions in liver fat content compared to baseline.
Key findings from the topline data of the Phase
1b portion of the study are summarized below.
Biomarker |
CB4211 (25 mg)(n = 11) |
Placebo(n = 9) |
Difference from Placebo |
ALT(% reduction from baseline) |
-21% |
|
4% |
|
-25* |
Proportion of subjects with >17 U/L decrease in ALT(1) |
27% |
|
11% |
|
16% |
|
AST(% reduction from baseline) |
-28% |
|
-11% |
|
-17%* |
Glucose (% reduction from baseline) |
-6% |
|
0% |
|
-6%* |
ALT: Alanine aminotransferase. AST: Aspartate aminotransferase.
*Statistically significant versus placebo, p<0.05 by unpaired t
test(1) A decrease in ALT by 17 U/L or more is significantly
associated with histologic response in NASH (Loomba R et al.
Gastroenterology, 2019; 156 (1): 88-95)
MRI-PDFF Data |
CB4211 (25 mg)(n = 11) |
Placebo(n = 9) |
Baseline Liver Fat Content (LFC) |
21.1% |
|
15.9% |
|
Percent Reduction in LFC (Absolute) |
-5.03% |
|
-4.88% |
|
Proportion of Responders Achieving >30% Relative Reduction in
LFC |
36% |
|
33% |
|
MRI-PDFF: Magnetic resonance imaging – proton density fat
fraction.
“The results from the Phase 1b CB4211 study are
promising,” stated Dr. Rohit Loomba, MD, MHSc, Professor of
Medicine, Director, NAFLD Research Center, and Director of
Hepatology, University of California at San Diego. “Demonstrating
significant reductions of this magnitude in both serum ALT and AST
relative to placebo after only four weeks suggests a potential for
improvement in liver health if we continue to see further
improvements over a longer period of time in patients with NASH.
Improvements in serum ALT and AST are key predictors of histologic
response independent of liver fat change; CB4211 shows great
promise as a potential candidate for further development in NASH
for this growing epidemic of silent and progressive liver
disease.”
The results from both portions of the study
indicate that CB4211 was well-tolerated and appeared safe with no
serious adverse events. The only adverse events occurring in
>10% of subjects receiving CB4211 in the four-week Phase 1b
portion of the study were transient and generally mild to moderate
injection site reactions.
“We are pleased with the positive outcome of our
first human trial of CB4211 and look forward to working with
disease experts to explore the next steps for our CB4211 program,”
stated Dr. Joseph Sarret, CohBar’s Chief Executive Officer. “These
impressive results validate our novel approach of using the
mitochondrial genome as a valuable source of potential therapeutic
peptides to treat serious systemic diseases.”
The Phase 1a stage of the study was a double
blind, placebo-controlled single ascending dose and multiple
ascending dose assessment of safety, tolerability, and
pharmacokinetics over one week in 65 healthy adults, to select the
most appropriate dose for the Phase 1b stage. The Phase 1b study
was a randomized, double-blind, placebo-controlled evaluation of a
25 mg dose of CB4211 given once daily by subcutaneous injection for
four weeks in 20 obese subjects with nonalcoholic fatty liver
disease (NAFLD). The primary endpoints were 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. This study was conducted at four sites.
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.
The company is continuing to analyze the data
and plans to present additional results and analyses at a future
scientific meeting.
Conference Call:Date: August 10, 2021Time: 5:00
p.m. ET (2:00 p.m. PT)
Conference Audio
- Dial-in U.S. and Canada: (877)
300-8521
- Dial-in International: (412)
317-6026
- Conference ID No.: 10159293
Slide Presentation
- Please visit
https://us02web.zoom.us/j/84796437737?pwd=R2t0eEFRVDVlVDVZMTdhT0pGWVVsUT09
and enter password CWBR, or
- Go to www.cohbar.com and click on
CohBar Q2 2021 Investor Presentation at the top of homepage.
For individuals participating in the Investor
Call and Slide Presentation, please call into the conference audio
and log into Zoom approximately 10 minutes prior to its start.
Please note, no audio will be available through Zoom.
An audio replay of the call will be available
beginning at 8:00 p.m. Eastern Time on August 10, 2021, through
11:59 p.m. Eastern Time on August 31, 2021. To access the recording
please dial (844) 512-2921 in the U.S. and Canada, or (412)
317-6671 internationally, and reference Conference ID# 10159293.
The audio recording along with the slide presentation will also be
available at www.cohbar.com during the same period.
About CB4211
CB4211 is a first-in-class mitochondria based
therapeutic (MBT) that recently completed a Phase 1a/1b clinical
study for the treatment 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. 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, recently completed a Phase 1a/1b
clinical trial for NASH and obesity. In addition, CohBar has four
preclinical programs with the most advanced being CB5138-3 for
idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases,
which is currently in IND-enabling studies. The preclinical
programs also include the CB5064 Analogs for acute respiratory
distress syndrome (ARDS) including 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; 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; 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 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
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