NEW DELHI — A new monoclonal antibody treatment has shown encouraging safety and effectiveness results for patients with primary sclerosing cholangitis, a rare and chronic liver disease for which no approved drug therapy currently exists.
Researchers from the University of California, Davis tested an anti-inflammatory and anti-fibrotic monoclonal antibody called nebokitug and found it to be safe and potentially beneficial for patients with the condition. The findings were published in the American Journal of Gastroenterology.
“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.”
Primary sclerosing cholangitis is a rare disease that causes ongoing inflammation and scarring of the bile ducts, which carry bile from the liver to the small intestine to aid digestion. Damage to these ducts leads to bile buildup in the liver, resulting in progressive liver injury.
The exact cause of PSC remains unclear, but most patients also suffer from inflammatory bowel disease, suggesting a strong link between intestinal inflammation and liver damage.
Symptoms may include fatigue, itching, and jaundice, although some patients remain symptom-free in the early stages. There is currently no cure for PSC, and treatment focuses on managing complications. In advanced cases, liver transplantation is often the only option.
Nebokitug is a laboratory-developed antibody designed to block CCL24, a protein involved in inflammation and fibrosis. In PSC patients, elevated levels of CCL24 are found around bile ducts, where they contribute to scarring and liver damage. Previous studies have shown that blocking this protein can reduce inflammatory and fibrotic processes.
In the Phase 2 clinical trial, 76 PSC patients across five countries were randomly assigned to receive nebokitug at two different doses or a placebo through intravenous infusions every three weeks for a total of 15 weeks. The primary objective of the study was to assess safety.
Results showed that nebokitug was safe and well tolerated. Patients receiving the treatment, particularly those with more advanced liver scarring, showed improvements in key indicators such as liver stiffness and fibrosis markers compared with those who received placebo.
Researchers said the findings support further investigation of nebokitug as a potential disease-modifying therapy for primary sclerosing cholangitis. (Source: IANS)
