Seladelpar, a medication aimed at treating primary biliary cholangitis, was tested in a phase 3 trial involving patients who didn't respond well to the standard treatment, ursodeoxycholic acid.
The trial showed that a significantly higher percentage of patients taking seladelpar achieved a biochemical response and normalized alkaline phosphatase levels compared to those on placebo.
Additionally, seladelpar was more effective in reducing itchiness, with patients reporting greater relief from pruritus than those receiving placebo, although some adverse events were noted.
Pruritus, a severe itching condition, significantly affects patients with primary biliary cholangitis (PBC), and seladelpar treatment shows promise in alleviating this symptom while also reducing bile acid levels.
In a study, serum IL-31 levels were measured in patients taking seladelpar or a placebo, revealing a strong correlation between IL-31 levels and the severity of pruritus as well as bile acid levels.
Results indicated that seladelpar caused significant reductions in both IL-31 and bile acids, supporting the idea that these reductions may explain the medication's effectiveness in relieving itching in PBC patients.
- Seladelpar, a selective PPARδ agonist, shows promise in improving liver injury markers and reducing fibrosis in a mouse model of nonalcoholic steatohepatitis (NASH), both when used alone and in combination with other agents like liraglutide and selonsertib.
- The study demonstrated significant plasma liver function improvements and robust declines in liver steatosis and fibrosis through various treatments, highlighting the potential of combining seladelpar with different therapeutics to enhance treatment effectiveness.
- Gene expression analysis revealed that seladelpar promotes lipid oxidation and metabolic changes, suggesting it may work well alongside different mechanisms of action for tackling the challenges posed by NASH and liver fibrosis.
Seladelpar is a selective drug targeting receptors that help manage conditions like primary biliary cholangitis (PBC) by reducing cholestasis, inflammation, and itching.
A long-term study evaluated seladelpar's safety and effectiveness in PBC patients, involving 106 individuals treated for up to 2 years.
Results showed no serious side effects, and an increase in positive treatment responses over two years, indicating that seladelpar significantly improved liver function markers.
The text discusses the challenges of assessing drug-induced liver injury (DILI) in clinical trials for metabolic dysfunction-associated steatohepatitis (MASH) without routine liver biopsies.
It details the efforts of the Liver Forum, which organized webinars and formed a Histology Working Group to develop consensus documents on the role of liver biopsy in DILI assessment during MASH trials from 2020 to 2022.
The findings suggest that while liver biopsy is not always definitive, histologic evaluation can provide essential insights that influence patient management, clarify the nature of liver injury, and inform drug development decisions.