CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, today announced that the last subject has completed their final visit in the Phase 1b stage of the CB4211 clinical study for nonalcoholic steatohepatitis (NASH) and obesity. The company currently expects to release topline data in early July 2021.
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 were 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 would like to thank CohBar’s clinical collaborators, staff, and clinical participants for their commitment to completing this study during the ongoing pandemic,” stated Steven Engle, Chief Executive Officer. “NASH continues to be an emerging epidemic affecting millions of people worldwide with no approved drug therapies.”
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.
Note: 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.