CohBar has commenced a Phase la/lb clinical trial to evaluate CB4211, a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity.

As part of the double-blind, placebo-controlled trial, the safety, tolerability, and pharmacokinetics of CB4211 will be examined following single and multiple-ascending doses in healthy subjects.

The trial’s final Phase lb stage will assess the safety, tolerability, and activity of CB4211 in obese subjects with non-alcoholic fatty liver diseases (NAFLD).

Assessments will also include changes in liver fat evaluated by magnetic resonance imaging-proton density fat fraction (MRI-PDFF), body weight, and biomarkers associated with NASH and obesity.

CohBar CSO Kenneth Cundy said: “The successful completion of our preclinical studies, filing and clearance of the investigational new drug (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.

“NASH is estimated to affect around 12% of adults in the US and there is currently no approved treatment available for the disease.”

“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.”

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CB4211 is a mitochondria-based therapeutic that has shown significant therapeutic potential in preclinical models of NASH and obesity.

It is an enhanced analogue of MOTS-c, a naturally occurring, mitochondrial-derived peptide (MDP), which was discovered in 2012 by CohBar founder Dr Pinchas Cohen and his academic partners and has been shown to play an important role in regulating metabolism.

NASH is estimated to affect around 12% of adults in the US and there is currently no approved treatment available for the disease.