CohBar Announces First Subjects Dosed in its Phase 1b Clinical Trial for CB4211 Under Development for NASH and Obesity

MENLO PARK, CA, USA I August 24, 2020 I CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, announced today that the first subjects have been dosed with CB4211 in the Phase 1b stage of its Phase 1a/1b clinical trial for NASH and obesity. The Phase 1b study is a double-blind, placebo-controlled evaluation of one dose level of CB4211 given once a day for four weeks in twenty obese subjects with NAFLD. This study is designed to assess the potential effects of CB4211 on liver fat, body weight, and various biomarkers that are relevant to NASH, obesity and metabolic disease. Subjects are 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. The study resumed in July after a pause in March due to the COVID-19 pandemic.

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.

“We are pleased to have made another key step towards evaluating the therapeutic potential of CB4211 and our technology platform,” said Steven Engle, CohBar’s Chief Executive Officer. “NASH is a complex disease with a large and growing unmet medical need with over 30 million patients at risk and no approved treatments in the U.S. Experts believe that more than one treatment approach will be needed, similar to the way other diseases are treated, like diabetes. We believe CB4211 is well positioned because it has a mechanism of action that is different from any other potential NASH treatment now in clinical development. In addition, it has demonstrated in preclinical studies a potential therapeutic synergy with GLP-1 agonists, which are already used in many diabetic NASH patients. We look forward to completing this study with topline data currently projected in Q1 2021 within the constraints currently imposed by COVID-19 on the study.”

About CB4211

CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT), 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. 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 because of 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 currently has four preclinical programs: CB5138 Analogs for fibrotic diseases, CB5064 Analogs for COVID-19 associated ARDS and type 2 diabetes, MBT5 Analogs for CXCR4-related cancer and orphan diseases, and MBT3 Analogs for cancer immunotherapy.


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