Primary Biliary Cholangitis (PBC) treatment

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GSK's Linerixibat Poised to Address Substantial Unmet Need for the Treatment of Pruritus Associated with Primary Biliary Cholangitis, According to Spherix Global Insights
GlobeNewswire News Room· 2025-07-17 17:00
Core Insights - The treatment landscape for primary biliary cholangitis (PBC) has significantly evolved with the recent approvals of Gilead's Livdelzi (seladelpar) and Ipsen's Iqirvo (elafibranor), marking progress in disease management [1] - Pruritus remains a significant unmet need for PBC patients, with many suffering from moderate to severe symptoms that impact their quality of life [2] Treatment Developments - GSK's linerixibat, an ileal bile acid transporter (IBAT) inhibitor, has had its New Drug Application accepted by the FDA for treating cholestatic pruritus in PBC patients, with a target action date of March 24, 2026 [3] - Gastroenterologists express a high likelihood of incorporating linerixibat into treatment if approved, noting its potential for significant symptom reduction despite concerns over side effects like abdominal pain and diarrhea [3] Market Analysis - Spherix Global Insights' Market Dynamix™ service provides analysis on markets expected to undergo significant changes in the next three to five years, focusing on market size, treatment approaches, unmet needs, and expert opinions on pipeline agents [4] - The service aims to track emerging developments in the PBC treatment landscape and pipeline, highlighting the ongoing demand for effective therapies targeting pruritus [3][4]
Karolinska Development’s portfolio company Umecrine Cognition presents data validating novel clinical scale in PBC at EASL 2025
Globenewswire· 2025-05-07 06:50
Core Insights - Umecrine Cognition, a portfolio company of Karolinska Development, is presenting new clinical scale data for Primary Biliary Cholangitis (PBC) at the EASL Congress 2025 in Amsterdam [1][2]. Company Overview - Karolinska Development AB holds a 73% ownership stake in Umecrine Cognition [5]. - The company focuses on identifying and investing in breakthrough medical innovations in the Nordic region, aiming to develop these into commercial products [6][8]. Drug Development - Umecrine Cognition is developing golexanolone, a drug candidate currently in a Phase 2a clinical study for PBC [2]. - The newly developed CGI-S-PBC™ scale is designed to evaluate symptom severity in PBC patients, which cannot be measured by conventional laboratory tests [3]. Clinical Research - The CGI-S-PBC™ scale expands on the PBC-40 patient-reported outcome measure and has been validated in two separate studies [3]. - Abstracts summarizing the validation and implementation of CGI-S-PBC™ will be presented at the EASL Congress, focusing on its role as a clinical trials outcome tool [4].