The first abstract demonstrates that the improvements of MACK-3, a diagnostic test for metabolic dysfunction-associated steatohepatitis, parallel the histological response to lanifibranor therapy in patients with MASH/NASH, in the NATIVE Phase IIb clinical trial.The second abstract brings additional evidence supporting the role of intrahepatic vascular alterations in the development of MASLD-related portal hypertension and the progression to MASH and highlights the potential of lanifibranor in addressing the different components of MASH disease including vascular alterations.
Daix (France), Long Island City (New York, United States), May 22, 2024 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), also known as non-alcoholic steatohepatitis (“NASH”), and other diseases with significant unmet medical needs, today announced that two scientific abstracts have been selected for poster presentation at the upcoming International Liver Congress™ 2024 hosted by the European Association for the Study of the Liver (EASL) on June 5-8, 2024 in Milan, Italy.
The first abstract evaluates the correlation of the response of the biomarker algorithm MACK-3 with the improvement of liver histology as well as markers of cardiometabolic health with lanifibranor treatment. MACK-3 is composed of HOMA-IR, AST and CK-18 and has been validated against histology as a diagnostic marker for active MASH/NASH with fibrosis. The authors demonstrated that the decrease in MACK-3 value at the end of a 24 week-treatment period was significantly higher among the patients treated with lanifibranor which were qualified as responders for the histological endpoints of “MASH/NASH resolution and fibrosis improvement”, “Fibrosis improvement without worsening of MASH/NASH” and “MASH/NASH resolution without fibrosis worsening, compared to patients treated with lanifibranor but qualified as non-responders for the endpoints. Similar results were observed for improvement of NAS, SAF, and individual liver lesions: steatosis, lobular inflammation, and ballooning. MACK-3 improvement correlated as well as with increase of adiponectin levels and decrease of Pro-C3, a circulating marker of fibrogenesis, following therapy with lanifibranor. These results warrant additional study to evaluate MACK-3 as a potential marker for the evaluation of a treatment response to lanifibranor.
The second abstract evaluates the effect of the pan-PPAR agonist, lanifibranor, on the improvement of liver histology as well as vascular alterations in a model of early MASLD. An increase in intrahepatic vascular resistance related to endothelial dysfunction in MASLD can be a potential driver of disease progression. The authors demonstrated that in a model of early MASLD, lanifibranor improved steatosis, normalized the mean arterial blood pressure, strongly decreased the portal pressure in-vivo and normalized the transhepatic pressure gradient ex-vivo. Furthermore, lanifibranor also decreased the reactivity to the vasoconstrictor methoxamine and normalized the hyporeactivity to vasodilator acetylcholine. The results from the collaboration between the University of Antwerp and Inventiva support the role of intrahepatic vascular alterations in the development of MASLD-related portal hypertension as well as in the progression to MASH and highlight the potential of lanifibranor in addressing all the components of MASH disease.
The details of the presentations are as follows:
Abstracts :
Abstract #1 title: "Improvements in MACK-3, a diagnostic test for active metabolic dysfunction-associated steatohepatitis, parallel response to lanifibranor therapy" Poster identifier: SAT-206 Presentation type: Poster presentation Authors: Michael P Cooreman, Sven Francque, Philippe Huot-Marchant, Lucile Dzen, Martine Baudin, Jean-Louis Junien, Pierre Broqua, Manal F Abdelmalek, Jérôme Boursier Date: Saturday June 8, 2024 – 8:30-17:00 (CEST) Abstract #2 title: "Altered liver vascular biology occurring in early stages of metabolic dysfunction-associated steatotic liver disease is significantly improved by the pan-peroxisome proliferator-activated receptor agonist lanifibranor, associating with improved liver histology" Poster identifier: THU-258-YI Presentation type: Poster presentation Authors: Shivani Chotkoe, Guillaume Wettstein, Jean-Louis Junien, Luisa Vonghia, Denise van der Graaff, Joris De Man, Benedicte De Winter, Wilhelmus J. Kwanten, Sven Francque Date: Thursday 6, 2024 – 8:30-17:00 (CEST)
Inventiva will also be present with a booth, and we are inviting you to visit us from Wednesday, June 5th until Saturday, June 8th at booth #N4 located in the exhibition hall 3 of the conference center.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH/NASH and other diseases with significant unmet medical need. The Company benefits from a strong expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing one clinical candidate, has a pipeline of two preclinical programs and continues to explore other development opportunities to add to its pipeline.
Inventiva’s lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with MASH/NASH, a common and progressive chronic liver disease for which there are currently no approved therapies.
Inventiva’s pipeline also includes odiparcil, a drug candidate for the treatment of adult MPS VI patients. As part of Inventiva’s decision to focus clinical efforts on the development of lanifibranor, it suspended its clinical efforts relating to odiparcil and is reviewing available options with respect to its potential further development. Inventiva is also in the process of selecting a candidate for its Hippo signaling pathway program.
The Company has a scientific team of approximately 90 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly-owned research and development facility.
Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com
Contacts InventivaPascaline ClercEVP, Strategy and Corporate Affairsmedia@inventivapharma.com +1 240 620 9175Brunswick GroupTristan Roquet Montegon /Aude Lepreux /Matthieu BenoistMedia relationsinventiva@brunswickgroup.com +33 1 53 96 83 83Westwicke, an ICR CompanyPatricia L. BankInvestor relationspatti.bank@westwicke.com
+1 415 513-1284
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Inventiva - PR - EASL Abstracts - EN - 05 22 2024
