CohBar (CWBR) Reports Complete Enrollment in Phase 1b Clinical Trial for CB4211 Under Development for NASH and Obesity
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CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, today announced the completion of enrollment in the Phase 1b stage of the CB4211 clinical study for nonalcoholic steatohepatitis (NASH) and obesity. The company currently expects topline data at the end of the second quarter based on projected timing of the last subject visit and other factors. The company plans to announce the completion of the last subject visit, which is currently anticipated in April 2021. For more information, please join the company’s quarterly call on March 30, 2021 at 5:00pm ET/2:00pm PT.
The Phase 1b study is a randomized, double-blind, placebo-controlled evaluation of one dose level of CB4211 given once a day for four weeks in obese subjects with non-alcoholic fatty liver disease (NAFLD). The primary endpoints are 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 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.
“We are pleased to have reached another important milestone with the completion of enrollment in our Phase 1b clinical study,” stated Steven Engle, CohBar’s Chief Executive Officer. “NASH is an emerging epidemic affecting millions of people worldwide, many of whom do not realize the disease is progressing. It remains an unmet medical need with no approved drugs.”
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.
CB4211 is 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.
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