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Alagille Syndrome

New treatment shows promise for patients with primary biliary cholangitis

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Seladelpar, a peroxisome proliferator-activated receptor delta agonist, has demonstrated significant efficacy in treating primary biliary cholangitis (PBC), according to results of a Phase 3 trial.

The trial showed that seladelpar resulted in a higher percentage of patients achieving a biochemical response and normalization of alkaline phosphatase levels compared to the placebo group. Additionally, seladelpar effectively reduced pruritus (itchiness) in patients with moderate-to-severe symptoms.

In the 12-month, double-blind, placebo-controlled trial, patients who had either experienced an inadequate response to or unacceptable side effects with the standard treatment, ursodeoxycholic acid, were randomly assigned to receive either seladelpar at a dose of 10 mg daily or a placebo. The primary goal was to achieve a biochemical response, defined as specific reductions in alkaline phosphatase levels and a normal total bilirubin level after 12 months.

A significantly higher percentage of patients in the seladelpar group achieved a biochemical response compared to those in the placebo group (61.7% vs 20.0%). Similarly, normalization of alkaline phosphatase levels was observed in a greater proportion of seladelpar recipients (25.0% vs 0%).

Seladelpar also demonstrated efficacy in reducing pruritus. Patients who reported moderate-to-severe pruritus at the beginning of the trial experienced a greater reduction in itchiness with seladelpar compared to the placebo.

Reference
Hirschfield GM, Bowlus CL, Mayo MJ, et al; RESPONSE Study Group. A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis. N Engl J Med. 2024;390(9):783-794. doi: 10.1056/NEJMoa2312100. Epub 2024 Feb 21. PMID: 38381664.

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