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6-K: Linerixibat Shows Positive Phase Iii Results in Cholestatic Pruritus in Primary Biliary Cholangitis

6-K: Linerixibat Shows Positive Phase Iii Results in Cholestatic Pruritus in Primary Biliary Cholangitis

6-K：Linerixibat在治療原發性膽汁性膽管炎膽汁淤積性瘙癢症方面顯示出積極的III期結果
美股SEC公告 ·  11/19 21:11

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GSK announced positive Phase III results for linerixibat in treating cholestatic pruritus associated with primary biliary cholangitis (PBC). The GLISTEN trial met its primary endpoint, showing a statistically significant improvement in itch over 24 weeks compared to placebo. Linerixibat, an ileal bile acid transporter inhibitor, has the potential to be the first global therapy specifically indicated for PBC-related itch.PBC is a rare autoimmune liver disease affecting an estimated 510,000 people globally by 2030, with over 240,000 experiencing severe itch requiring treatment. Current therapies for cholestatic pruritus are inadequate, highlighting a significant unmet need. Linerixibat's preliminary safety results are consistent with prior studies, and it has received Orphan Drug Designation in both the US and EU.The full results of the GLISTEN trial will be presented at a future scientific congress. GSK's development of linerixibat addresses a root cause of cholestatic pruritus, potentially offering a new treatment option for PBC patients whose quality of life is significantly impacted by persistent itching.
GSK announced positive Phase III results for linerixibat in treating cholestatic pruritus associated with primary biliary cholangitis (PBC). The GLISTEN trial met its primary endpoint, showing a statistically significant improvement in itch over 24 weeks compared to placebo. Linerixibat, an ileal bile acid transporter inhibitor, has the potential to be the first global therapy specifically indicated for PBC-related itch.PBC is a rare autoimmune liver disease affecting an estimated 510,000 people globally by 2030, with over 240,000 experiencing severe itch requiring treatment. Current therapies for cholestatic pruritus are inadequate, highlighting a significant unmet need. Linerixibat's preliminary safety results are consistent with prior studies, and it has received Orphan Drug Designation in both the US and EU.The full results of the GLISTEN trial will be presented at a future scientific congress. GSK's development of linerixibat addresses a root cause of cholestatic pruritus, potentially offering a new treatment option for PBC patients whose quality of life is significantly impacted by persistent itching.
GSk宣佈了linerixibat在治療與原發性膽汁性膽管炎（PBC）相關的膽汁性瘙癢方面的積極III期結果。GLISTEN試驗達到了其主要終點，顯示在24周內與安慰劑相比，瘙癢有了統計學意義上的顯著改善。linerixibat是一種腸道膽汁酸轉運抑制劑，有潛力成爲首個專門用於治療PBC相關瘙癢的全球療法。PBC是一種罕見的自身免疫性肝病，到2030年估計將影響全球約510,000人，其中超過240,000人經歷嚴重的瘙癢，需要治療。當前針對膽汁性瘙癢的療法不足，突顯了顯著的未滿足需求。linerixibat的初步安全結果與之前的研究一致，並且在美國和歐盟均獲得了孤兒藥認證。GLISTEN試驗的完整結果將在未來的科學會議上公佈。GSK對linerixibat的開發解決了膽汁性瘙癢的根本原因，有可能爲那些由於持續瘙癢而生活質量顯著受影響的PBC患者提供新的治療選擇。
GSk宣佈了linerixibat在治療與原發性膽汁性膽管炎（PBC）相關的膽汁性瘙癢方面的積極III期結果。GLISTEN試驗達到了其主要終點，顯示在24周內與安慰劑相比，瘙癢有了統計學意義上的顯著改善。linerixibat是一種腸道膽汁酸轉運抑制劑，有潛力成爲首個專門用於治療PBC相關瘙癢的全球療法。PBC是一種罕見的自身免疫性肝病，到2030年估計將影響全球約510,000人，其中超過240,000人經歷嚴重的瘙癢，需要治療。當前針對膽汁性瘙癢的療法不足，突顯了顯著的未滿足需求。linerixibat的初步安全結果與之前的研究一致，並且在美國和歐盟均獲得了孤兒藥認證。GLISTEN試驗的完整結果將在未來的科學會議上公佈。GSK對linerixibat的開發解決了膽汁性瘙癢的根本原因，有可能爲那些由於持續瘙癢而生活質量顯著受影響的PBC患者提供新的治療選擇。
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