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Madrigal Pharmaceuticals to Present Multiple Rezdiffra™ (resmetirom) Abstracts in NASH/MASH at the AASLD Liver Meeting®

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Madrigal Pharmaceuticals (NASDAQ:MDGL) announced multiple presentations on Rezdiffra™ (resmetirom) at the upcoming AASLD Liver Meeting in San Diego (November 15-19, 2024). The company will present eleven abstracts, including two oral presentations featuring new results from the Phase 3 MAESTRO-NASH trial.

Rezdiffra, the first approved medication for NASH treatment, is a once-daily, oral, liver-directed thyroid hormone receptor THR-β agonist. In the pivotal Phase 3 trial, 80% of patients treated with Rezdiffra 100 mg showed improvement or stabilization of fibrosis. The drug is indicated for adults with noncirrhotic NASH with moderate to advanced liver fibrosis.

The presentations will cover various aspects, including the drug's effects on patients with different weight loss profiles, genetic risk factors, and its impact on liver enzymes.

Madrigal Pharmaceuticals (NASDAQ:MDGL) ha annunciato numerose presentazioni su Rezdiffra™ (resmetirom) al prossimo Congresso AASLD sul Fegato a San Diego (15-19 Novembre 2024). L'azienda presenterà undici abstract, comprese due presentazioni orali con nuovi risultati dalla sperimentazione di Fase 3 MAESTRO-NASH.

Rezdiffra, il primo farmaco approvato per il trattamento della NASH, è un agonista del recettore dell'ormone tiroideo THR-β diretto al fegato, assunto una volta al giorno per via orale. Nella sperimentazione cruciale di Fase 3, l'80% dei pazienti trattati con Rezdiffra 100 mg ha mostrato un miglioramento o una stabilizzazione della fibrosi. Il farmaco è indicato per adulti con NASH non cirrotica e fibrosi epatica da moderata a avanzata.

Le presentazioni copriranno vari aspetti, compresi gli effetti del farmaco su pazienti con diversi profili di perdita di peso, fattori di rischio genetici e il suo impatto sugli enzimi epatici.

Madrigal Pharmaceuticals (NASDAQ:MDGL) anunció múltiples presentaciones sobre Rezdiffra™ (resmetirom) en el próximo Congreso AASLD sobre el Hígado en San Diego (15-19 de noviembre de 2024). La compañía presentará once resúmenes, incluyendo dos presentaciones orales con nuevos resultados del ensayo de Fase 3 MAESTRO-NASH.

Rezdiffra, el primer medicamento aprobado para el tratamiento de la NASH, es un agonista del receptor de hormona tiroidea THR-β que se toma por vía oral una vez al día y está dirigido al hígado. En el ensayo pivotal de Fase 3, el 80% de los pacientes tratados con Rezdiffra 100 mg mostraron mejoría o estabilización de la fibrosis. El medicamento está indicado para adultos con NASH no cirrótica con fibrosis hepática moderada a avanzada.

Las presentaciones cubrirán varios aspectos, incluidos los efectos del medicamento en pacientes con diferentes perfiles de pérdida de peso, factores de riesgo genéticos y su impacto sobre las enzimas hepáticas.

마드리갈 제약회사 (NASDAQ:MDGL)는 2024년 11월 15일부터 19일까지 샌디에이고에서 열리는 AASLD 간 관련 회의에서 레즈디프라™ (레즈메티롬)에 대한 여러 발표를한다고 발표했습니다. 이 회사는 3상 MAESTRO-NASH 시험의 새로운 결과를 포함하여 11개의 초록을 발표할 예정입니다.

레즈디프라는 NASH 치료를 위해 승인된 첫 번째 약물로, 하루에 한 번 경구 투여하는 간지향성 갑상선 호르몬 수용체 THR-β 효능제입니다. 중대한 3상 시험에서 레즈디프라 100mg으로 치료받은 환자의 80%가 섬유증의 개선 또는 안정화를 보였습니다. 이 약물은 증상이 없는 간염(NASH)이 있는 성인 및 중등도에서 중증 섬유증 환자에게 사용됩니다.

발표에서는 약물이 다른 체중 감소 프로파일, 유전적 위험 요소 및 간 효소에 미치는 영향을 포함한 다양한 측면을 다룰 예정입니다.

Madrigal Pharmaceuticals (NASDAQ:MDGL) a annoncé plusieurs présentations sur Rezdiffra™ (resmetirom) lors de la prochaine réunion AASLD sur le foie à San Diego (du 15 au 19 novembre 2024). L'entreprise présentera onze résumés, y compris deux présentations orales mettant en avant de nouveaux résultats de l'essai de Phase 3 MAESTRO-NASH.

Rezdiffra, le premier médicament approuvé pour le traitement de la NASH, est un agoniste du récepteur des hormones thyroïdiennes THR-β à action hépatique, administré par voie orale une fois par jour. Dans l'essai pivot de Phase 3, 80 % des patients traités avec Rezdiffra 100 mg ont montré une amélioration ou une stabilisation de la fibrose. Le médicament est indiqué pour les adultes souffrant de NASH non cirrhotique avec fibrose hépatique modérée à avancée.

Les présentations couvriront divers aspects, y compris les effets du médicament sur les patients avec différents profils de perte de poids, les facteurs de risque génétiques et son impact sur les enzymes hépatiques.

Madrigal Pharmaceuticals (NASDAQ:MDGL) hat mehrere Präsentationen zu Rezdiffra™ (Resmetirom) auf dem bevorstehenden AASLD-Lebermeeting in San Diego (15.-19. November 2024) angekündigt. Das Unternehmen wird elf Abstracts präsentieren, darunter zwei mündliche Präsentationen mit neuen Ergebnissen aus der Phase-3-Studie MAESTRO-NASH.

Rezdiffra, das erste zugelassene Medikament zur Behandlung von NASH, ist ein einmal täglich oral einzunehmender, leberspezifischer Agonist des Schilddrüsenhormonrezeptors THR-β. In der entscheidenden Phase-3-Studie zeigten 80 % der Patienten, die mit Rezdiffra 100 mg behandelt wurden, eine Verbesserung oder Stabilisierung der Fibrose. Das Medikament ist für Erwachsene mit nicht-zirrhotischer NASH und moderater bis schwerer Leberfibrose angezeigt.

Die Präsentationen werden verschiedene Aspekte abdecken, einschließlich der Auswirkungen des Medikaments auf Patienten mit unterschiedlichen Gewichtsverlustprofilen, genetischen Risikofaktoren und dessen Einfluss auf die Leberenzyme.

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CONSHOHOCKEN, Pa., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), today announced multiple resmetirom data presentations at the upcoming American Association for the Study of Liver Diseases (AASLD) Liver Meeting, taking place from November 15-19, 2024 in San Diego.

Bill Sibold, Chief Executive Officer of Madrigal, stated, “This will be the first AASLD Liver Meeting following the approval of Rezdiffra earlier this year, and the entire NASH community feels energized with new momentum. It is an exciting moment for Madrigal and for the field as a whole. At the same time, we recognize that NASH remains the leading cause of liver transplant among women in the U.S. and second-leading cause in men, so there is an urgent need to continue advancing patient care. The Liver Meeting will provide a valuable opportunity to share the latest resmetirom clinical research, engage with healthcare providers, and reinforce Madrigal’s leadership position in NASH.”

Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, added, “The eleven abstracts Madrigal will be presenting at The Liver Meeting support Rezdiffra’s position as the foundational therapy for NASH with moderate to advanced fibrosis and offer important insights into the burden of the disease on patients and the health system. We look forward to sharing two oral presentations of new results from the Phase 3 MAESTRO-NASH trial and multiple posters from our clinical development program that will help guide patient care and further NASH research.”

Rezdiffra (resmetirom) is a once-daily, oral, liver-directed thyroid hormone receptor THR-β agonist designed to target key underlying causes of NASH. It is the first approved medication for the treatment of NASH. In the pivotal Phase 3 MAESTRO-NASH biopsy trial, Rezdiffra achieved both fibrosis improvement and NASH resolution primary endpoints, and 80% of patients treated with Rezdiffra 100 mg experienced improvement or stabilization of fibrosis. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

Madrigal data presentations at AASLD The Liver Meeting, 2024

  • Oral presentation: “Effect of resmetirom or placebo in NASH fibrosis patients with <5% or ≥5% weight loss and/or on baseline GLP-1 therapy in the MAESTRO-NASH 52-week serial liver biopsy study” [Sunday, Nov. 17 at 9:15 a.m. PST. Presenter: Mazen Noureddin]
  • Oral presentation: “Resmetirom effects on NASH with liver fibrosis in patients with NASH genetic risk alleles” [Sunday, Nov. 17 at 11:30 a.m. PST. Presenter: Naga Chalasani]
  • Poster: “Resmetirom therapy of MASH-associated Child Pugh A cirrhosis reduces estimated risk for clinical outcome based on HepQuant RISK ACE model” [Presenter: Gregory Everson]
  • Poster: “Baseline characteristics in well-compensated NASH cirrhosis patients diagnosed with or without a liver biopsy in MAESTRO-NASH-OUTCOMES, a clinical outcome Phase 3 study assessing the effect of resmetirom in well compensated NASH cirrhosis” [Presenter: Meena Bansal]
  • Poster: “Use of non-invasive tests to diagnose and follow NASH with liver fibrosis patients treated with resmetirom” [Presenter: Naim Alkhouri]
  • Poster: “Liver enzymes reductions from baseline over time in resmetirom treated patients in a Phase 3 study, MAESTRO-NASH” [Presenter: Seth Baum]
  • Poster: “Validating pre-identified morphological baseline features for predicting fibrosis progression in MAESTRO-NASH” [Presenter: Jörn Schattenberg]
  • Poster: “Impact of resmetirom on statin pharmacokinetics and safety in Phase 1 studies and MAESTRO-NASH” [Presenter: Seth Baum]
  • Poster: “Assessment of resmetirom efficacy (80 mg vs. 100 mg) stratified by baseline body mass index and weight in patients from the MAESTRO-NASH trial” [Presenter: Mazen Noureddin]
  • Poster: “Risk of incident extrahepatic cancers among Medicare patients with non-alcoholic steatohepatitis (NASH)” [Presenter: Robert Gish]
  • Poster: “Current multi-dimensional view of non-alcoholic steatohepatitis (NASH)/ metabolic dysfunction-associated steatohepatitis (MASH) global epidemiological rates” [Presenter: Michael Charlton]

Additionally, Madrigal will be exhibiting at booth #1239 and hosting two product theaters on Sunday and Monday, November 17 and 18, at 10:00 a.m. PST.

About NASH

Nonalcoholic steatohepatitis (NASH) is a more advanced form of nonalcoholic fatty liver disease (NAFLD). NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Additionally, patients with NASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality.

Once patients progress to NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically. When a patient with NASH progresses to cirrhosis, their risk of liver-related mortality increases by more than 42 percent. NASH is rapidly becoming the leading cause of liver transplantation in the U.S.

Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis. Madrigal is focusing on approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of liver specialist physicians during the launch of Rezdiffra.

NASH is also known as metabolic dysfunction-associated steatohepatitis (MASH). In 2023, global liver disease medical societies and patient groups came together to rename the disease, with the goal of establishing an affirmative, non-stigmatizing name and diagnosis. Nonalcoholic fatty liver disease (NAFLD) was renamed metabolic dysfunction-associated steatotic liver disease (MASLD); NASH was renamed MASH; and an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. In addition to liver disease, patients with MASH have at least one related comorbid condition (e.g., obesity, hypertension, dyslipidemia, or type 2 diabetes).

About Rezdiffra

What is Rezdiffra?

Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.

It is not known if Rezdiffra is safe and effective in children (under 18 years old).

This indication is approved based on improvement of NASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra.

Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you:

  • have any liver problems other than NASH.
  • have gallbladder problems or have been told you have gallbladder problems, including gallstones.
  • are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works.
  • Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, or cyclosporine to suppress your immune system, because Rezdiffra is not recommended in patients taking these medicines.
  • Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of Rezdiffra?

Rezdiffra may cause serious side effects, including:

  • liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice), pain or tenderness in the upper middle or upper right area of your stomach (abdomen).        
  • gallbladder problems. Gallbladder problems such as gallstones, inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with NASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting.

The most common side effects of Rezdiffra include: diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, constipation.

These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Madrigal at 1-800-905-0324.

Please see the full Prescribing Information, including Patient Information, for Rezdiffra.

About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of NASH. For more information, visit www.madrigalpharma.com.

Forward-Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding: Rezdiffra and its expected use for treating NASH with moderate to advanced fibrosis. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Madrigal’s control, and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties and other factors are described under the heading “Risk Factors” in Madrigal’s Annual Report on Form 10-K for the year ended December 31, 2023, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and in subsequent filings made by Madrigal with the Securities and Exchange Commission from time to time. These forward-looking statements are based on Madrigal's current expectations and speak only as of the date of this press release. Except as required by law, Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Investor Contact
Tina Ventura, IR@madrigalpharma.com

Media Contact
Christopher Frates, media@madrigalpharma.com


FAQ

What are the main findings from Rezdiffra's Phase 3 MAESTRO-NASH trial for MDGL stock?

In the Phase 3 MAESTRO-NASH trial, Rezdiffra achieved both fibrosis improvement and NASH resolution primary endpoints, with 80% of patients treated with the 100 mg dose experiencing improvement or stabilization of fibrosis.

How many abstracts will Madrigal Pharmaceuticals (MDGL) present at the 2024 AASLD Liver Meeting?

Madrigal Pharmaceuticals will present eleven abstracts at the 2024 AASLD Liver Meeting, including two oral presentations and multiple posters from their clinical development program.

What is the approved indication for Madrigal's Rezdiffra in NASH treatment?

Rezdiffra is approved for treating adults with noncirrhotic NASH with moderate to advanced liver fibrosis (stages F2 to F3), in conjunction with diet and exercise.

When and where will Madrigal Pharmaceuticals (MDGL) present at the AASLD Liver Meeting 2024?

The presentations will take place at the AASLD Liver Meeting in San Diego from November 15-19, 2024, with oral presentations scheduled for November 17.

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