MENLO PARK, Calif., Aug. 24, 2020 (GLOBE NEWSWIRE) -- 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 drugsbased onnovel analogs ofpeptide sequencesdiscovered by CohBar scientists in the mitochondrial genome, some of whichhave been shown tohave the potential to regulatekey processes inmultiplesystems andorgans 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."