New Delhi, Dec 24 A new monoclonal antibody treatment has shown promising results for a rare liver disease called primary sclerosing cholangitis (PSC).
The team from the University of California-Davis, US, tested an anti-inflammatory and anti-fibrotic monoclonal antibody known as nebokitug and found it to be safe and potentially effective in patients with PSC.
Published in the American Journal of Gastroenterology, the results offer encouraging news for patients with PSC, for which there are currently no effective treatments short of liver transplantation.
"In the trial, nebokitug demonstrated that it has the potential to change the lives of patients with PSC by reducing fibrosis and inflammation, which should lead to improved outcomes," said Christopher Bowlus, chief of Gastroenterology and Hepatology at UC Davis Health.
"These results are good news for patients with PSC, who are in desperate need of an effective, FDA-approved therapy."
PSC is a rare, chronic liver disease that causes inflammation and scarring of the bile ducts. These ducts carry bile from the liver to the small intestine to help digest fats. When they become damaged and narrow, bile builds up in the liver, leading to liver injury over time.
The exact cause of PSC is not fully understood, but most patients also have inflammatory bowel disease, suggesting a direct link between intestinal inflammation and the liver.
Symptoms can include fatigue, itching, and jaundice, though some people have no symptoms at first. There is no cure, and treatment focuses on managing symptoms and complications. In advanced cases, a liver transplant may be needed.
Nebokitug is a lab-made antibody designed to block a protein called CCL24. This protein plays a role in inflammation and scarring by interacting with certain inflammatory cells in the liver.
In PSC, CCL24 levels are higher than normal and are found around the bile ducts, where they contribute to liver damage. Studies have shown that blocking CCL24 can reduce these harmful processes.
For the Phase 2 trial, 76 PSC patients across five countries were randomly assigned to receive nebokitug at two different doses or a placebo through an IV every three weeks for 15 weeks. The main goal was to check safety.
Results showed nebokitug was safe and well-tolerated. Patients, especially those with more advanced liver scarring, had improvements in key measures like liver stiffness and fibrosis markers compared to placebo.
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