CohBar, Inc. Announces Positive Results from Preclinical NASH Study of its Lead Drug Candidates
Menlo Park, California – February 21, 2017 – CohBar, Inc. (OTCQX: CWBR and TSXV: COB.U), a preclinical stage biotechnology company focused on developing mitochondria based therapeutics (MBTs) to treat age-related diseases, announced today that it has completed a study to evaluate the potential efficacy of its lead drug candidates, MOTS-c peptide analogs CB4209 and CB4211, in a well-established preclinical model of nonalcoholic steatohepatitis (NASH). With these positive study results, the Company continues to advance its lead drug candidates through IND enabling activities, with plans to initiate human clinical trials in early 2018.
The recently completed study investigated the therapeutic effects of CB4209 and CB4211 in the widely used STAM™ mouse model for NASH. In this model, treatment with either CB4209 or CB4211 resulted in a significant reduction of the non-alcoholic fatty liver disease (NAFLD) activity score, or NAS, a composite measure of steatosis (fat accumulation), inflammation and hepatocyte ballooning (cellular injury).
“NASH, as well as obesity and type-2 diabetes, are potential clinical targets for our lead drug candidates. These results clearly support findings from our earlier preclinical studies in diet induced obesity models, where we saw significant decreases in liver fat and favorable reductions in biomarkers associated with NASH,” said Simon Allen, CohBar’s CEO. “We plan to submit our preclinical NASH results during 2017 for presentation at a relevant scientific meeting as we continue to advance our lead drug candidates towards the clinic.”
About NAFLD and NASH
Non-alcoholic fatty liver disease (NAFLD) is the buildup of extra fat in liver cells that is not due to alcohol consumption and tends to develop in people who are overweight or obese or have diabetes, high cholesterol or high levels of triglycerides. Non-alcoholic steatohepatitis (NASH) is a more severe form of NAFLD characterized by swelling of the liver that eventually may lead to scarring (cirrhosis), and over time to liver cancer or liver failure. NAFLD affects as much as 34% of the US population while as many as 12% of US adults may have NASH. Currently, there are no FDA approved treatments for NAFLD or NASH.
About CohBar’s Clinical Development Program
CohBar’s lead clinical development program is based on MOTS-c, a mitochondrial-derived peptide discovered in 2012 by the Company’s founders and their academic collaborators, whose research has shown that MOTS-c plays a significant role in the regulation of metabolism. The Company has developed optimized analogs of the MOTS-c peptide, CB4209 and CB4211, which have demonstrated significant therapeutic potential in preclinical models for the treatment of obesity and nonalcoholic steatohepatitis (NASH). CohBar is currently advancing these drug candidates through IND-enabling activities with plans to initiate clinical trials of the final candidate in early 2018.
CohBar (OTCQX: CWBR and TSXV: COB.U) is a preclinical 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 are focused 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, including obesity, fatty liver disease, type-2 diabetes, cancer, cardiovascular and neurodegenerative disorders. To date, the Company and its founders have discovered more than 50 biologically active mitochondrial peptides.
This news release contains forward-looking information about CohBar’s CB4209 and CB4211 drug candidate program including statements about the potential therapeutic benefits of these drug candidates and other MBTs, and statements regarding CohBar’s plans to pursue IND-enabling activities and potential future clinical studies in humans. These forward-looking statements are based on current expectations, estimates and projections that involve a number of risks and uncertainties that could cause actual results to differ materially from those implied by such statements. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated commencement and completion dates for IND-enabling and initial clinical studies, as well as the possibility of unfavorable study results, including unfavorable new data and additional analyses of existing data; risks associated with initial data, including the risk that results of additional pre-clinical or clinical studies may be different from (including less favorable than) the earlier data results and may not support further clinical development; whether and when any investigational new drug application may be filed with regulatory authorities for CB4209 or CB4211; whether and when regulatory authorities may approve any such applications, and other decisions by regulatory authorities that could affect the availability or commercial potential of CB4209 or CB4211. Additional risks and uncertainties include CohBar’s ability to retain key personnel, expand its research operations, and obtain financing necessary to continue its operations and fund its drug 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 securities laws. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For additional company information, please visit www.cohbar.com.
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