CohBar (NASDAQ:CWBR) dosed first subjects with CB4211 in the Phase 1b stage of its Phase 1a/1b clinical trial for non-alcoholic steatohepatitis (NASH) and obesity.
The Phase 1b study is designed to evaluate one dose level of CB4211, given once a day for four weeks, in 20 obese subjects with non-alcoholic fatty liver disease in order to assess potential effects on liver fat, body weight, and various biomarkers that are relevant to NASH, obesity and metabolic disease.
CB4211 is the first mitochondria-based therapeutic to enter clinical testing. In a statement, Steven Engle, CEO of CohBar, said CB4211’s mechanism of action 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, he added.
CohBar expects to report topline data in the first quarter of 2021, within the constraints currently imposed by COVID-19 on the study.