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Organovo to Present Clinical Data of FXR314 in Phase 2 MASH in an Oral Presentation at The Liver Meeting Sponsored by the American Association for the Study of Liver Diseases

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Organovo Holdings (Nasdaq: ONVO) announces that its lead clinical stage drug, FXR314, will be featured in an oral presentation at The Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD). The presentation, scheduled for November 17, 2024, will be delivered by Dr. Eric Lawitz of the Texas Liver Institute and will discuss findings from the FXR314 Phase 2 MASH study. The presentation will cover pharmacokinetics, safety, and efficacy of this novel non-bile acid FXR agonist in patients with metabolic dysfunction-associated steatohepatitis.

Organovo Holdings (Nasdaq: ONVO) annuncia che il suo farmaco principale in fase clinica, FXR314, sarà presentato in un intervento orale durante The Liver Meeting, sponsorizzato dall'American Association for the Study of Liver Diseases (AASLD). L'intervento, programmato per il 17 novembre 2024, sarà tenuto dal Dr. Eric Lawitz del Texas Liver Institute e discuterà i risultati dello studio FXR314 Phase 2 MASH. La presentazione tratterà la farmacocinetica, la sicurezza e l'efficacia di questo nuovo agonista FXR non acido biliare in pazienti con steatoepatite associata a disfunzione metabolica.

Organovo Holdings (Nasdaq: ONVO) anuncia que su fármaco principal en etapa clínica, FXR314, será presentado en una charla oral en The Liver Meeting, patrocinado por la Asociación Americana para el Estudio de las Enfermedades del Hígado (AASLD). La presentación, programada para el 17 de noviembre de 2024, será realizada por el Dr. Eric Lawitz del Texas Liver Institute y discutirá los hallazgos del estudio FXR314 Phase 2 MASH. La presentación abarcará farmacocinética, seguridad y eficacia de este novedoso agonista FXR no ácido biliar en pacientes con esteatohepatitis asociada a disfunción metabólica.

Organovo Holdings (Nasdaq: ONVO)는 자사의 주요 임상 단계 약물인 FXR314가 미국 간 질환 연구 협회(AASLD) 주최의 The Liver Meeting에서 구두 발표될 것이라고 발표했습니다. 발표는 2024년 11월 17일로 예정되어 있으며, 텍사스 간 연구소의 Eric Lawitz 박사가 진행하며 FXR314 Phase 2 MASH 연구의 결과를 논의할 것입니다. 발표에서는 대사 기능 장애와 관련된 지방간염 환자에서 이 새로운 비담즙산 FXR 작용제의 약리학적 동태, 안전성 및 유효성에 대해 다룰 것입니다.

Organovo Holdings (Nasdaq: ONVO) annonce que son médicament phare en phase clinique, FXR314, sera présenté lors d'une communication orale au The Liver Meeting, sponsorisé par l'American Association for the Study of Liver Diseases (AASLD). La présentation, prévue pour le 17 novembre 2024, sera faite par le Dr. Eric Lawitz de l'Institut du foie du Texas et discutera des résultats de l'. La présentation couvrira la pharmacocinétique, la sécurité et l'efficacité de cet agoniste FXR non acide biliaire chez les patients atteints de stéatohépatite associée à une dysfonction métabolique.

Organovo Holdings (Nasdaq: ONVO) gibt bekannt, dass sein führendes klinisches Arzneimittel, FXR314, in einer mündlichen Präsentation bei The Liver Meeting vorgestellt wird, das von der American Association for the Study of Liver Diseases (AASLD) gesponsert wird. Die Präsentation, die für den 17. November 2024 angesetzt ist, wird von Dr. Eric Lawitz des Texas Liver Institute gehalten und wird die Ergebnisse der FXR314 Phase 2 MASH-Studie erörtern. Die Präsentation behandelt die Pharmakokinetik, Sicherheit und Wirksamkeit dieses neuartigen, nicht-gallensauren FXR Agonisten bei Patienten mit metabolisch bedingter Steatohepatitis.

Positive
  • Lead drug FXR314 reaching Phase 2 clinical trial stage
  • Selection for oral presentation at major industry conference (AASLD)
Negative
  • None.

SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces that its lead clinical stage drug, FXR314 will be featured in an oral presentation at The Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD). The presentation, by Dr. Eric Lawitz of the Texas Liver Institute, will describe the findings from the FXR314 Phase 2 MASH study. The meeting will be held November 15-19, 2024 in San Diego, California.

Details include:

PresenterDr Eric Lawitz, Texas Liver Institute

Session Date / Time:11/17/2024, 2:00 pm - 3:30 pm PST

Session Title:MASLD and MASH - New Therapies 

Type:Abstract Parallel

Presentation Title:PHARMACOKINETICS, SAFETY AND EFFICACY OF THE NOVEL NON-BILE ACID FXR AGONIST FXR314 IN PATIENTS WITH METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS: RESULTS FROM A PHASE 2 STUDY
 
Presentation Time:3:00 pm - 3:15 pm PST

About Organovo
Organovo is a clinical stage biotechnology company that is developing drugs that are demonstrated to be effective in three-dimensional (3D) human tissues as candidates for drug development. The company’s lead molecule, FXR314, is on the path for Phase 2 investigation in inflammatory bowel disease and has potential application in metabolic liver disease and oncology. The company has proprietary technology used to build 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease.  For more information visit Organovo's website at www.organovo.com.

Forward Looking Statements
Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on May 31, 2024, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on November 8, 2024 and the Registration Statement on Form S-1 (File No. 333-282841). You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events. 

Contact
CORE IR
pr@coreir.com

Source: Organovo, Inc.


FAQ

What will be presented about Organovo's FXR314 at The Liver Meeting 2024?

Dr. Eric Lawitz will present Phase 2 study results on FXR314's pharmacokinetics, safety, and efficacy in patients with metabolic dysfunction-associated steatohepatitis (MASH) on November 17, 2024.

When and where is Organovo (ONVO) presenting at The Liver Meeting 2024?

Organovo will present on November 17, 2024, from 3:00-3:15 PM PST at The Liver Meeting in San Diego, California.

What type of drug is Organovo's (ONVO) FXR314?

FXR314 is a novel non-bile acid FXR agonist being developed for metabolic dysfunction-associated steatohepatitis (MASH).

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