CohBar has initiated dosing in their Phase 1b trial of CB4211, which is a treatment for nonalcoholic steatohepatitis (NASH). The biotechnology company focuses on mitochondria based therapies with the goal of treating chronic diseases and extending lifespans.
Nonalcoholic steatohepatitis (NASH) is a disease that is characterized by a buildup of fat in the liver that causes inflammation and liver damage. This disease affects those who drink very little or not at all, but it mimics the liver disease of heavy drinkers. The liver damage has the potential to cause enough scar tissue that it prevents the liver from functioning. It affects up to one quarter of the people in the United States.
There is a debate about the cause of NASH. Some healthcare professionals believe that it is inherited, while others think it is triggered by environmental factors. The exact cause is unknown, but there are risk factors that are known to increase the chance of developing NASH. These include obesity, type 2 diabetes, high cholesterol, and metabolic syndrome. NASH is not always symptomatic, and it does not always progress. Symptoms can vary from person to person. Some of these symptoms include weakness, fatigue, weight loss, nausea, vomiting, loss of appetite, jaundice, itching, mental confusion, abdominal pain, swelling in the legs or abdomen, and spider-like blood vessels.
The first step in diagnosing this disease is a blood test. Other tests will follow in order to rule out other conditions. An ultrasound confirms the diagnosis. After a doctor confirms that it is NASH, treatment options include weight loss, lowering one’s cholesterol, avoiding alcohol, controlling one’s diabetes, a healthy diet, and exercise.
About the Trial
This study will be double-blind and placebo-controlled with the goal of evaluating CB4211’s effect on body weight, liver fat, and various biomarkers. 20 participants will be treated daily for four weeks, all of whom were required to have at least 10% liver fat.
The treatment itself is a mitochondria based therapy. CohBar researchers discovered a number of peptide sequences in the mitochondrial genome, and they believe that some of them have the ability to regulate various processes within the body. CB4211 is an analog of MOTS-c, specifically. Researchers are excited about this treatment, in part because of the positive results in preclinical trials.
As NASH faces an unmet medical need, medical professionals and patients are hopeful that this trial yields positive results. Read more about it here.