GSK's Investigational Liver Disease Candidate Hits Primary Goal In Late-Stage Study To Treat Relentless Itch In Some Patients

Benzinga11-20 02:24

On Tuesday, GSK plc (NYSE:GSK) released the headline results of the GLISTEN global phase 3 trial evaluating linerixibat in adults with cholestatic pruritus (relentless itch) associated with primary ...

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The trial recruited PBC patients with moderate to severe itch who were receiving stable doses of guideline-suggested therapies for pruritus, were treatment nave, or had been previously treated.The preliminary safety results are generally consistent with those seen in prior studies of linerixibat. Further analysis of these data is ongoing.People who have been diagnosed with PBC will reach 510,000 globally by 2030, and more than 240,000 people will experience relentless itch","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","BK4023":"应用软件","NICE":"NICE系统","IE00BFMHRM44.USD":"NEUBERGER BERMAN GLOBAL EQUITY MEGATRENDS \"A\" (USD) ACC","BK4566":"资本集团","BK4532":"文艺复兴科技持仓","LU1829250122.USD":"高盛欧洲核心股票组合Acc","PBC":"Prospect Capital Corp","SSI":"Stage Stores Inc","GSK":"葛兰素史克","BK4585":"ETF&股票定投概念","GSK.UK":"葛兰素史克","BK4588":"碎股"},"translate_title":"葛兰素史克的肝病候选药物在治疗某些患者持续瘙痒的后期研究中达到了主要目标","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"GSK":1,"NICE":1,"PBC":1,"SSI":1,"GSK.UK":0.6},"content_text":"On Tuesday, GSK plc (NYSE:GSK) released the headline results of the GLISTEN global phase 3 trial evaluating linerixibat in adults with cholestatic pruritus (relentless itch) associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease.\nGLISTEN met its primary endpoint, with linerixibat improving itch, as demonstrated by a statistically significant reduction from baseline in monthly itch score over 24 weeks versus placebo.\nAlso Read: GSK Raises Prospects For Withdrawn Blood Cancer Drug Blenrep To Return To US Market – Here’s Why\nThe trial recruited PBC patients with moderate to severe itch who were receiving stable doses of guideline-suggested therapies for pruritus, were treatment naïve, or had been previously treated.\nThe preliminary safety results are generally consistent with those seen in prior studies of linerixibat. Further analysis of these data is ongoing.\nKaivan Khavandi, SVP & Global Head, Respiratory/Immunology R&D, GSK, said: “Linerixibat has the potential to be the first global therapy specifically developed to treat itch in PBC.”\nPeople who have been diagnosed with PBC will reach 510,000 globally by 2030, and more than 240,000 people will experience relentless itch requiring treatment.\nThe full results of GLISTEN will be presented at a future scientific congress.\nInvestigational Linerixibat has been granted Orphan Drug Designation in the U.S. and EU.\nIn August this year, GSK requested a timeline adjustment, so the appraisal is expected to start in late September 2025. Submissions will be due around late November 2025.\nThis change allows the company more time to prepare a thorough and detailed submission for the National Institute for Health and Care Excellence (NICE).\nPrice Action: GSK stock is down 0.56% at $33.50 at the last check on Tuesday.\nRead Next:\n\nVipshop Beats Q3 Estimates Despite Sales Dip, Focuses On Long-Term Resilience\n\nUp Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market.\nGet the latest stock analysis from Benzinga?\n\nGSK (GSK): Free Stock Analysis Report\n\nThis article GSK's Investigational Liver Disease Candidate Hits Primary Goal In Late-Stage Study To Treat Relentless Itch In Some Patients originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"2","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.2","shortVersion":"4.29.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2484971418"}