{"title":"Evaluating the safety and efficacy of seladelpar for adults with primary biliary cholangitis.","authors":"Allyce Caines, Sheri Trudeau, Stuart C Gordon","doi":"10.1080/14656566.2024.2390120","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Seladelpar (MBX-8025) is a once-daily administered highly specific PPAR-δ agonist in Phase 3 and extension trials for use in patients with primary biliary cholangitis (PBC).</p><p><strong>Areas covered: </strong>This review provides background on current treatment options for PBC, and summarizes clinical trial data regarding the safety and effectiveness of seladelpar within the context of these treatments.</p><p><strong>Expert opinion: </strong>Clinical trials results demonstrate the safety and tolerability of seladelpar use for PBC, including in patients with cirrhosis. The primary composite endpoint (ALP <1.67 times ULN, decrease ≥ 15% from baseline, and TB ≤ULN) was met in 61.7% of the patients treated with seladelpar and in 20% receiving placebo (<i>p</i> < 0.001). Moreover, pruritus - a cardinal and often intractable symptom of PBC - was improved with seladelpar treatment, as were overall quality of life measurements. Improvements in markers of inflammation were likewise observed. These biochemical and clinical findings therefore represent landmark developments in PBC treatment and offer a therapeutic option for PBC.</p>","PeriodicalId":12184,"journal":{"name":"Expert Opinion on Pharmacotherapy","volume":" ","pages":"1517-1523"},"PeriodicalIF":2.5000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Opinion on Pharmacotherapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14656566.2024.2390120","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/11 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Seladelpar (MBX-8025) is a once-daily administered highly specific PPAR-δ agonist in Phase 3 and extension trials for use in patients with primary biliary cholangitis (PBC).
Areas covered: This review provides background on current treatment options for PBC, and summarizes clinical trial data regarding the safety and effectiveness of seladelpar within the context of these treatments.
Expert opinion: Clinical trials results demonstrate the safety and tolerability of seladelpar use for PBC, including in patients with cirrhosis. The primary composite endpoint (ALP <1.67 times ULN, decrease ≥ 15% from baseline, and TB ≤ULN) was met in 61.7% of the patients treated with seladelpar and in 20% receiving placebo (p < 0.001). Moreover, pruritus - a cardinal and often intractable symptom of PBC - was improved with seladelpar treatment, as were overall quality of life measurements. Improvements in markers of inflammation were likewise observed. These biochemical and clinical findings therefore represent landmark developments in PBC treatment and offer a therapeutic option for PBC.
简介：Seladelpar（MBX-8025）是一种每日给药一次的高度特异性PPAR-δ激动剂，目前正在进行原发性胆汁性胆管炎（PBC）患者的3期和延长期试验：本综述介绍了目前PBC治疗方案的背景，并总结了在这些治疗方案中有关舍拉德帕安全性和有效性的临床试验数据：临床试验结果证明了舍拉德帕治疗PBC（包括肝硬化患者）的安全性和耐受性。主要综合终点（ALP p
期刊介绍：
Expert Opinion on Pharmacotherapy is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles and original papers on newly approved/near to launch compounds mainly of chemical/synthetic origin, providing expert opinion on the likely impact of these new agents on existing pharmacotherapy of specific diseases.
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