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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 ·  2024/11/19 21:11

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GSK announced positive results from the GLISTEN Phase III trial of linerixibat for treating cholestatic pruritus in primary biliary cholangitis (PBC). The trial met its primary endpoint, demonstrating statistically significant improvement in itch over 24 weeks compared to placebo. The preliminary safety results align with previous studies, positioning linerixibat as potentially the first global therapy specifically targeting PBC-related itch.The drug targets a significant unmet medical need, as PBC is expected to affect 510,000 people globally by 2030, with over 240,000 experiencing severe itch requiring treatment. Current therapies for cholestatic pruritus show limited effectiveness and poor tolerability. PBC primarily affects women and can lead to liver failure if untreated.Linerixibat, an ileal bile acid transporter (IBAT) inhibitor, works by addressing a root cause of cholestatic pruritus. The drug has received Orphan Drug Designation in both the US and EU, though it is not yet approved anywhere. Full results from the GLISTEN trial will be presented at a future scientific congress.
GSK announced positive results from the GLISTEN Phase III trial of linerixibat for treating cholestatic pruritus in primary biliary cholangitis (PBC). The trial met its primary endpoint, demonstrating statistically significant improvement in itch over 24 weeks compared to placebo. The preliminary safety results align with previous studies, positioning linerixibat as potentially the first global therapy specifically targeting PBC-related itch.The drug targets a significant unmet medical need, as PBC is expected to affect 510,000 people globally by 2030, with over 240,000 experiencing severe itch requiring treatment. Current therapies for cholestatic pruritus show limited effectiveness and poor tolerability. PBC primarily affects women and can lead to liver failure if untreated.Linerixibat, an ileal bile acid transporter (IBAT) inhibitor, works by addressing a root cause of cholestatic pruritus. The drug has received Orphan Drug Designation in both the US and EU, though it is not yet approved anywhere. Full results from the GLISTEN trial will be presented at a future scientific congress.
GSk宣佈了linerixibat在治療原發性膽汁性膽管炎（PBC）引起的膽汁性瘙癢的GLISTEN III期試驗的積極結果。該試驗達到了主要終點，顯示在24周內與安慰劑相比，瘙癢症狀有統計學上的顯著改善。初步安全性結果與之前的研究一致，使linerixibat有可能成爲第一個專門針對PBC相關瘙癢的全球療法。該藥物針對一個顯著的未滿足的醫療需求，因爲預計到2030年，PBC將在全球影響510,000人，其中超過240,000人會經歷需要治療的嚴重瘙癢。目前針對膽汁性瘙癢的療法有效性有限，耐受性差。PBC主要影響女性，未經治療可能導致肝衰竭。Linerixibat是一種迴腸膽汁酸轉運蛋白（IBAT）抑制劑，通過解決膽汁性瘙癢的根本原因來發揮作用。該藥物已獲得美國和歐盟的孤兒藥認證，但尚未在任何地方獲得批准。GLISTEN試驗的完整結果將在未來的科學大會上發佈。
GSk宣佈了linerixibat在治療原發性膽汁性膽管炎（PBC）引起的膽汁性瘙癢的GLISTEN III期試驗的積極結果。該試驗達到了主要終點，顯示在24周內與安慰劑相比，瘙癢症狀有統計學上的顯著改善。初步安全性結果與之前的研究一致，使linerixibat有可能成爲第一個專門針對PBC相關瘙癢的全球療法。該藥物針對一個顯著的未滿足的醫療需求，因爲預計到2030年，PBC將在全球影響510,000人，其中超過240,000人會經歷需要治療的嚴重瘙癢。目前針對膽汁性瘙癢的療法有效性有限，耐受性差。PBC主要影響女性，未經治療可能導致肝衰竭。Linerixibat是一種迴腸膽汁酸轉運蛋白（IBAT）抑制劑，通過解決膽汁性瘙癢的根本原因來發揮作用。該藥物已獲得美國和歐盟的孤兒藥認證，但尚未在任何地方獲得批准。GLISTEN試驗的完整結果將在未來的科學大會上發佈。
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