Mirum Pharmaceuticals to Showcase Data from its LIVMARLI and Volixibat Clinical Programs at AASLD’s The Liver Meeting

Business Wire11-14

- Late-breaker presentation to feature data from VANTAGE study evaluating volixibat in primary biliary cholangitis FOSTER CITY, Calif., November 14, 2024--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. ...

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FOSTER CITY, Calif., November 14, 2024----Mirum Pharmaceuticals, Inc.  today announced that it will present data at the American Association for the Study of Liver Disease’s  The Liver Meeting, taking place November 15-19, 2024, in San Diego, California.Enclosed below are the titles that have been accepted for presentation during the meeting. The abstracts are available via the AASLD website. Full analyses will be available following their presentation within the Publications & Presentation section on Mirum’s website.Abstract #4400: Impact of Maralixibat on Caregiver Burden for Patients with Alagille Syndrome and Progressive Familial Intrahepatic CholestasisMonday, November 18 from 1:00-2:00pm during Poster Session IV, Poster Hall CPresented by Dr. Natasha Dilwali, The Johns Hopkins School of Medicine, Baltimore, Maryland, USA. Abstract #4436: Bile Acid Subspecies are Cor","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4532":"文艺复兴科技持仓","BSEP":"Innovator U.S. Equity Buffer ETF - September","PBC":"Prospect Capital Corp","BK4588":"碎股","BK4520":"美国基建股","PSC":"Principal U.S. Small-Cap Multi-Factor ETF","ALGS":"Aligos Therapeutics, Inc.","BK4585":"ETF&股票定投概念","FSV":"FirstService Corporation","BK4079":"房地产服务","BK4505":"高瓴资本持仓","BK4006":"钢铁","X":"美国钢铁","IBAT":"IShares Energy Storage & Materials ETF","BK4516":"特朗普概念","MIRM":"Mirum Pharmaceuticals, Inc.","BK4139":"生物科技"},"translate_title":"Mirum Pharmaceuticals将在AASLD肝脏会议上展示其LIVMARLI和Volixibat临床项目的数据","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"X":1,"PSC":1,"PBC":1,"IBAT":1,"FSV":1,"BSEP":1,"ALGS":1,"MIRM":0.9},"content_text":"- Late-breaker presentation to feature data from VANTAGE study evaluating volixibat in primary biliary cholangitis\nFOSTER CITY, Calif., November 14, 2024--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that it will present data at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting®, taking place November 15-19, 2024, in San Diego, California.\nEnclosed below are the titles that have been accepted for presentation during the meeting. The abstracts are available via the AASLD website. Full analyses will be available following their presentation within the Publications & Presentation section on Mirum’s website.\nPresentations\nAbstract #5038: Volixibat for Cholestatic Pruritus in Primary Biliary Cholangitis: An Adaptive, Randomized, Placebo-controlled Phase 2b Trial (VANTAGE): Interim Results**Late-breaker poster presentation**Monday, November 18 from 1:00-2:00pm, Poster Hall CPresented by Dr. Kris Kowdley, Washington State University, Seattle, Washington, USA\nAbstract #184: Improvements in Pruritus are Associated with Improvements in Growth in Patients with Progressive Familial Intrahepatic Cholestasis: Data from the MARCH-ON trial**Oral presentation**Sunday, November 17 from 12:15-12:30pm during the ‘Advances in Pediatric Liver Disease’ session, Ballroom 6CPresented by Dr. Alexander Miethke, Cincinnati Children’s Hospital, Cincinnati, Ohio, USA\nAbstract #4347: Pilot Study of Volixibat Co-administered with OCA for Primary Biliary Cholangitis (PBC) Treatment: The VLX-602 TrialMonday, November 18 from 1:00-2:00pm during Poster Session IV, Poster Hall CPresented by Dr. Kris Kowdley, Washington State University, Seattle, Washington, USA\nAbstract #4400: Impact of Maralixibat on Caregiver Burden for Patients with Alagille Syndrome and Progressive Familial Intrahepatic CholestasisMonday, November 18 from 1:00-2:00pm during Poster Session IV, Poster Hall CPresented by Dr. Natasha Dilwali, The Johns Hopkins School of Medicine, Baltimore, Maryland, USA\nAbstract #4419: Real-world Use of Maralixibat in Biliary Atresia: A Case SeriesMonday, November 18 from 1:00-2:00pm during Poster Session IV, Poster Hall CPresented by Dr. Natasha Dilwali, The Johns Hopkins School of Medicine, Baltimore, Maryland, USA\nAbstract #4432: The Relationship Between Serum Bile Acids and Event-Free Survival Following the Use of Maralixibat for Progressive Familial Intrahepatic Cholestasis: Data from MARCH/MARCH-ONMonday, November 18 from 1:00-2:00pm during Poster Session IV, Poster Hall CPresented by Professor Richard Thompson, King’s College London, United Kingdom\nAbstract #4436: Bile Acid Subspecies are Correlated with Pruritus and Bilirubin Improvement in PFIC Patients Treated with Maralixibat: Data from MARCH and MARCH-ONMonday, November 18 from 1:00-2:00pm during Poster Session IV, Poster Hall CPresented by Professor Henkjan Verkade, University of Groningen, Groningen, Netherlands\nAlagille Syndrome Patient & Physician Fireside DiscussionDuring the meeting, Mirum will host a session spotlighting a pediatric hepatologist and an adult patient living with ALGS. Dr. Ajay Jain, St. Louis University, will discuss clinical insights and patient, Emma, will share her experience with LIVMARLI.Sunday, November 17 from 1:30-2:00 p.m. in Exhibit Hall TLM Theater #2\nAbout LIVMARLI® (maralixibat) oral solution\nLIVMARLI® (maralixibat) oral solution is an orally administered, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for two pediatric cholestatic liver diseases. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the U.S. three months of age and older and in Europe for patients two months of age and older. It is also approved in the U.S. for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) 12 months of age and older and in Europe for the treatment of PFIC in patients three months of age and older. For more information for U.S. residents, please visit LIVMARLI.com.\nLIVMARLI has received Breakthrough Therapy designation for ALGS and PFIC type 2 and orphan designation for ALGS and PFIC. To learn more about ongoing clinical trials with LIVMARLI, please visit Mirum’s clinical trials section on the company’s website.\nIMPORTANT SAFETY INFORMATION\nLimitation of Use: LIVMARLI is not for use in PFIC type 2 patients who have a severe defect in the bile salt export pump (BSEP) protein.\nLIVMARLI can cause side effects, including:\nLiver injury. Changes in certain liver tests are common in patients with Alagille syndrome and PFIC but can worsen during treatment. These changes may be a sign of liver injury. In PFIC, this can be serious or may lead to liver transplant or death. Your healthcare provider should do blood tests and physical exams before starting and during treatment to check your liver function. Tell your healthcare provider right away if you get any signs or symptoms of liver problems, including nausea or vomiting, skin or the white part of the eye turns yellow, dark or brown urine, pain on the right side of the stomach (abdomen), bloating in your stomach area, loss of appetite or bleeding or bruising more easily than normal.\nStomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea and stomach pain. Your healthcare provider may advise you to monitor for new or worsening stomach problems including stomach pain, diarrhea, blood in your stool or vomiting. Tell your healthcare provider right away if you have any of these symptoms more often or more severely than normal for you.\nA condition called Fat Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat is common in patients with Alagille syndrome and PFIC but may worsen during treatment. Your healthcare provider should do blood tests before starting and during treatment and may monitor for bone fractures and bleeding which have been reported as common side effects.\nUS Prescribing Information EU SmPC Canadian Product Monograph\nAbout Mirum Pharmaceuticals, Inc.\nMirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Mirum has three approved medications: LIVMARLI® (maralixibat) oral solution, CHOLBAM® (cholic acid) capsules, and CHENODAL® (chenodiol) tablets.\nLIVMARLI, an IBAT inhibitor, is approved for the treatment of two rare liver diseases affecting children and adults. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome in the U.S. (three months and older), in Europe (two months and older), and in other regions globally. It is also approved in the U.S. in cholestatic pruritus in PFIC patients 12 months of age and older; in Europe, it is approved for patients with PFIC three months of age and older. Mirum is also initiating the Phase 3 EXPAND study, a label expansion opportunity for LIVMARLI in additional settings of cholestatic pruritus. CHOLBAM is FDA-approved for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders in patients who show signs or symptoms or liver disease. CHENODAL has received medical necessity recognition by the FDA to treat patients with cerebrotendinous xanthomatosis (CTX).\nMirum’s late-stage pipeline includes two investigational treatments for debilitating liver diseases. Volixibat, an IBAT inhibitor, is being evaluated in two potentially registrational studies including the Phase 2 VISTAS study for primary sclerosing cholangitis (PSC) and Phase 2b VANTAGE study for primary biliary cholangitis. Volixibat has been granted Breakthrough Therapy Designation for the treatment of cholestatic pruritus in patients with PBC. Lastly, chenodiol, has been evaluated in a Phase 3 clinical study, RESTORE, to treat patients with CTX, with positive topline results reported in 2023. Mirum has submitted a new drug application with the FDA for the approval of chenodiol to treat CTX in the U.S.\nTo learn more about Mirum, visit mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and Twitter (X).\nForward-Looking Statements\nThis press release includes forward-looking statements pertaining to the Company’s planned participation at a scientific conference, including data presentation title and synopsis for both commercial and clinical programs, which may include discussion of the Company’s clinical and research data relating to the therapeutic potential and/or commercial viability of LIVMARLI or other Company product candidates in various liver disease indications and in patient populations that are investigational only. Words such as \"will,\" \"could,\" \"would,\" \"potential\" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general and the other risks described in Mirum’s filings with the Securities and Exchange Commission. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. A further description of risks and uncertainties can be found in Mirum’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned \"Risk Factors,\" as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20241114053418/en/\nContacts\nMedia Contact:Erin Murphymedia@mirumpharma.com\nInvestor Contact:Andrew McKibbenir@mirumphama.com","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0},"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":"4.29.3","shortVersion":"4.29.3","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/2483994807"}