April 20, 2024
Seladelpar Shows Promising Results for Patients with Primary Biliary Cholangitis

Seladelpar Shows Promising Results for Patients with Primary Biliary Cholangitis

A recent study published in the New England Journal of Medicine suggests that the peroxisome proliferator-activated receptor delta (PPARδ) agonist seladelpar may hold significant benefits for patients diagnosed with primary biliary cholangitis. Led by Gideon M. Hirschfield, Ph.D., from the University Health Network in Toronto, the phase 3 clinical trial involved 193 patients with primary biliary cholangitis who either had an insufficient response to or experienced unacceptable side effects from ursodeoxycholic acid.

The participants were randomly divided into two groups, with one group receiving a daily dose of 10 mg of oral seladelpar while the other group received a placebo. The primary goal of the study was to observe a biochemical response in the patients. The results indicated that a higher percentage of patients in the seladelpar group (61.7%) experienced a biochemical response compared to those in the placebo group (20.0%).

Moreover, the study showed that a significant number of patients who were treated with seladelpar achieved normalization of their alkaline phosphatase levels (25.0%) in contrast to those in the placebo group (0%). Patients who received seladelpar also reported a greater reduction in pruritus, as indicated by the score on the pruritus numerical rating scale.

The findings demonstrate that seladelpar not only triggered biochemical responses but also alleviated pruritus in patients with primary biliary cholangitis who had previously shown an inadequate response to or experienced adverse effects from ursodeoxycholic acid. Adverse events were reported in 86.7% of patients in the seladelpar group and 84.6% in the placebo group, with 7.0% and 6.2% of patients experiencing serious adverse events, respectively.

In conclusion, the study suggests that seladelpar, a selective PPARδ agonist, shows promise in providing relief for patients with primary biliary cholangitis. The results highlight the potential of seladelpar in improving the biochemical responses and quality of life for individuals diagnosed with this condition.

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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it