CohBar Initiates Clinical Study with First-in-human Dosing of CB4211, a Novel Mitochondria Based Therapeutic for the Treatment of NASH

CohBar (NASDAQ:CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, today announced that it has initiated a Phase 1a/1b safety and biomarker study of CB4211, its lead MBT candidate under development as a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity.  CB4211 is the first mitochondria based therapeutic to enter clinical testing.

As quoted in the press release:

“The successful completion of our preclinical studies, filing and clearance of the IND, and initiation of this clinical study represent major milestones for the company, as we begin to validate the therapeutic potential of peptides encoded in the mitochondrial genome,” said Kenneth C. Cundy, CohBar CSO. “The peptide showed impressive efficacy in preclinical models, and this clinical study is designed to assess safety, as well as to provide an early indication of the therapeutic potential of CB4211 in the setting of NASH and obesity.”

The double-blind, placebo-controlled clinical study will initially assess the safety, tolerability, and pharmacokinetics of CB4211 following single and multiple-ascending doses in healthy subjects. The final Phase 1b stage of the study will be an assessment of safety, tolerability, and activity in obese subjects with non-alcoholic fatty liver diseases (NAFLD). Assessments will include changes in liver fat assessed by MRI-PDFF, body weight, and biomarkers relevant to NASH and obesity.

Click here to read the full press release.