Seladelpar Efficacy in Treating Primary Biliary Cholangitis
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on April 5th, 2024
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Primary biliary cholangitis, a rare liver disorder impacting the bile duct and leading to toxic bile acid buildup, currently has only one FDA-approved treatment: ursodeoxycholic acid. However, this medication is linked to significant adverse effects like pruritus and shows only a moderate response rate. Seladelpar, a novel agent capable of activating the proliferator–activated receptor Delta (PPAR-delta) to mitigate bile acid accumulation, underwent evaluation for its efficacy in treating primary biliary cholangitis in a recent study.
The phase 3 clinical trial enrolled 193 patients aged between 18 and 75 years diagnosed with primary biliary cholangitis for an average duration of approximately 8 years, all of whom had received treatment with ursodeoxycholic acid within the past 12 months. The mean ALT level was around 48 U/Liter, while the average AST level was approximately 40 U/Liter. Participants were randomly assigned to receive either a placebo or Seladelpar in addition to ursodeoxycholic acid. In instances where ursodeoxycholic acid was contraindicated due to adverse effects, it was not administered. Seladelpar was orally administered at a daily dose of 10 mg. Following 12 months of treatment, Seladelpar effectively controlled alkaline phosphatase and bilirubin levels in 61.7% of patients, representing a 41.7% improvement compared to the control group. Furthermore, Seladelpar treatment significantly alleviated pruritus severity in patients. The researchers attributed this dermatological response to a reduction in the pruritogenic cytokine interleukin-31.
The phase 3 clinical trial enrolled 193 patients aged between 18 and 75 years diagnosed with primary biliary cholangitis for an average duration of approximately 8 years, all of whom had received treatment with ursodeoxycholic acid within the past 12 months. The mean ALT level was around 48 U/Liter, while the average AST level was approximately 40 U/Liter. Participants were randomly assigned to receive either a placebo or Seladelpar in addition to ursodeoxycholic acid. In instances where ursodeoxycholic acid was contraindicated due to adverse effects, it was not administered. Seladelpar was orally administered at a daily dose of 10 mg. Following 12 months of treatment, Seladelpar effectively controlled alkaline phosphatase and bilirubin levels in 61.7% of patients, representing a 41.7% improvement compared to the control group. Furthermore, Seladelpar treatment significantly alleviated pruritus severity in patients. The researchers attributed this dermatological response to a reduction in the pruritogenic cytokine interleukin-31.