lanifibranor (IVA337) / Inventiva, Hepalys Pharma 
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 2 Diseases   2 Trials   2 Trials   202 News 


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  • ||||||||||  MASH 2B TRIALS- A SYSTEMATIC REVIEW () -  Oct 15, 2024 - Abstract #AASLD2024AASLD_2363;    
    Lanifibranor and icosabutate showed promise, especially in T2D patients. FGF21 analogues like efruxifermin improved fibrosis, while FGF19 trials had variable results.
  • ||||||||||  EVALUATION OF MASH DRUG EFFICACY USING LIVER ORGANOIDS BASED ON DRUG TARGET PATHWAYS () -  Oct 15, 2024 - Abstract #AASLD2024AASLD_2302;    
    Then, we administered the following drugs alone or in combination: Resmetirom (10 ?M), Lanifibranor (80 ?M), Firsocostat (20 ?M) and Liraglutide (20 ?M). Although accurately reproducing the lipid metabolism of actual patients is difficult, the organoid model was shown to be more appropriate for evaluating drug efficacy than the existing in vitro 2D cell models.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept, lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    Review, Journal:  Emerging Therapies for Non-Alcoholic Steatohepatitis (NASH): A Comprehensive Review of Pharmacological and Non-Pharmacological Approaches. (Pubmed Central) -  Oct 14, 2024   
    The evolving landscape of NASH research emphasizes the need for multidisciplinary approaches integrating advances in diagnostics, therapeutics, and digital health technologies. As the field progresses, the focus remains on developing more effective, personalized, and accessible strategies for preventing, diagnosing, and treating NASH, with the ultimate goal of improving outcomes for patients affected by this increasingly prevalent liver disease.
  • ||||||||||  lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    Preclinical, Journal:  Lanifibranor Reduces Inflammation and Improves Dyslipidemia in Lysosomal Acid Lipase-Deficient Mice. (Pubmed Central) -  Sep 19, 2024   
    These findings suggest the necessity of a further combined study of lanifibranor with enzyme replacement therapy in Lal-/- mice to improve the phenotype. Moreover, there is a compelling rationale for conducting clinical trials to assess the efficacy of lanifibranor as a potential treatment option for LAL-D in humans.
  • ||||||||||  lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    Preclinical, Journal:  Mice hepatic organoids for modeling nonalcoholic fatty liver disease and drug response. (Pubmed Central) -  Aug 13, 2024   
    In conclusion, tissue structure, gene expression, and the response of mouse liver organoids to drugs can partially mimic in vivo liver tissue. Liver organoids can successfully construct NAFLD models for drug discovery research.
  • ||||||||||  lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    Journal:  MASLD/MASH and type 2 diabetes: two sides of the same coin? From single PPAR to pan-PPAR agonists. (Pubmed Central) -  Jun 9, 2024   
    Single PPAR agonists are approved for hypertriglyceridemia (PPAR?) and T2D (PPAR?), but these, as well as dual PPAR agonists, have shown mixed results as anti-MASH treatments in clinical trials. Agonists of all three PPAR isoforms have the potential to improve the full disease spectrum from insulin resistance to fibrosis, and correspondingly to improve cardiometabolic and hepatic health, as has been shown (phase II data) with the pan-PPAR agonist lanifibranor.
  • ||||||||||  lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    Pan-PPAR agonists directly target BK channels for the acute relaxation of pulmonary arteries. (PS-6; Poster board no. 13) -  May 31, 2024 - Abstract #ERS2024ERS_2078;    
    The observed vasoactive effects of pan-PPAR are dependent of BK channel activation, delineating direct PPAR agonism on BK channels. Suggesting Pan-PPAR agonists could hold promise as a therapeutic option for patients with PH
  • ||||||||||  Review, Journal:  Advancements in pharmacological treatment of NAFLD/MASLD: a focus on metabolic and liver-targeted interventions. (Pubmed Central) -  Apr 29, 2024   
    The first is to repurpose drugs that originally targeted T2DM and/or obesity, such as pioglitazone, glucagon-like peptide 1 receptor agonists (liraglutide and semaglutide), multi-agonists (tirzepatide and retatrutide), and sodium-glucose transporter 2 inhibitors...Among those, we focused on resmetirom, fibroblast growth factor 21 analogs, and lanifibranor, as they are currently in Phase 3 of their clinical trial development...As occurs in many chronic conditions, combination therapy might lead to better outcomes. In the case of non-alcoholic steatohepatitis, we speculate that drugs treating underlying metabolic co-morbidities might play a bigger role in the earlier stages of disease, while liver-targeting molecules will become vital in patients with more advanced disease in terms of inflammation and fibrosis.
  • ||||||||||  dorsomorphin (Compound C) / EMD Serono, lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    Journal:  Development of a high throughput system to screen compounds that revert the activated hepatic stellate cells to a quiescent-like state. (Pubmed Central) -  Apr 17, 2024   
    Using aHSCs prepared from human induced pluripotent stem cells, we found that aHSCs were reverted to a quiescent-like state by a combination of chemical compounds that either inhibit or activate a signaling pathway, Lanifibranor, SB431542, Dorsomorphin, retinoic acid, palmitic acid and Y27632, in vitro. Based on these results, we established a high throughput system to screen agents that induce deactivation and demonstrate that a single chemical compound can induce deactivation.
  • ||||||||||  lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    Improvements in MACK-3, a diagnostic test for active metabolic dysfunction-associated steatohepatitis, parallel response to lanifibranor therapy (Poster Area) -  Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_2105;    
    Based on these results, we established a high throughput system to screen agents that induce deactivation and demonstrate that a single chemical compound can induce deactivation. MACK-3 is a practical diagnostic algorithm for fibrotic MASH that also shows good correlation with improvement of histological disease activity and fibrosis, as well as with improvement of non-invasive biomarkers following therapy with lanifibranor, and thus warrants further study as a potential marker for evaluation of treatment response.
  • ||||||||||  Lipaglyn (saroglitazar) / Zydus Lifesci, lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    APAP induced liver damage is prevented by activation of PPAR-gamma and PPAR-alpha (Poster Area) -  Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_1373;    
    PPAR-gamma activation is involved in the protection of E2f2-/- mice against APAP-induced hepatotoxicity. The activation of both PPARs confers protection against APAP- induced liver injury and might be consider as a potential treatment in the future.
  • ||||||||||  Clinical translatability of the GAN diet-induced obese and biopsy-confirmed mouse model of MASH (Poster Area) -  Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_1091;    
    agonist, 10 mg/kg, PO, QD), firsocostat (ACC inhibitor, 5 mg/kg, PO, QD), or vehicle for 12 weeks. GAN DIO-MASH mice faithfully reproduce histological outcomes of several compounds profiled in clinical trials for MASH, highlighting clinical translatability and utility of the model in preclinical drug development.
  • ||||||||||  lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease (clinicaltrials.gov) -  Feb 4, 2024   
    P2,  N=128, Completed, 
    Recruiting --> Active, not recruiting | N=63 --> 42 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Mar 2024 Recruiting --> Completed | N=54 --> 128 | Trial completion date: Apr 2024 --> Jun 2023 | Trial primary completion date: Apr 2024 --> Apr 2023
  • ||||||||||  lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    Preclinical, Journal, Metastases, Biopsy:  Semaglutide reduces tumor burden in the GAN diet-induced obese and biopsy-confirmed mouse model of NASH-HCC with advanced fibrosis. (Pubmed Central) -  Jan 2, 2024   
    Here, we profiled monotherapy with semaglutide (glucagon-like-receptor-1 receptor agonist) and lanifibranor (pan-peroxisome proliferator-activated receptor agonist) in a diet-induced obese (DIO) mouse model of NASH-HCC...In conclusion, the GAN DIO-NASH-HCC mouse is a clinical translational model of NASH-HCC. Semaglutide improves both NASH and tumor burden in GAN DIO-NASH-HCC mice, highlighting the suitability of this preclinical model for profiling novel drug therapies targeting NASH-HCC.
  • ||||||||||  lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    Trial completion:  A Pharmacokinetic Study of Lanifibranor in Healthy Adult Chinese Subjects (clinicaltrials.gov) -  Jan 1, 2024   
    P1,  N=24, Completed, 
    Semaglutide improves both NASH and tumor burden in GAN DIO-NASH-HCC mice, highlighting the suitability of this preclinical model for profiling novel drug therapies targeting NASH-HCC. Active, not recruiting --> Completed
  • ||||||||||  Lipaglyn (saroglitazar) / Zydus Lifesci, efruxifermin (AKR-001) / Amgen, lanifibranor (IVA337) / Inventiva
    Review, Journal:  Emerging therapeutic options for non-alcoholic fatty liver disease: A systematic review. (Pubmed Central) -  Sep 13, 2023   
    The data analyzed in this review showed clinically significant improvement in individual histological features of NAFLD in both animal and human trials for all four classes, as well as good safety profiles (P < 0.05). We believe this compilation of information will have positive clinical implications in obtaining an FDA-approved therapy for NAFLD.
  • ||||||||||  Lipaglyn (saroglitazar) / Zydus Lifesci, Parmodia (pemafibrate) / Kowa, lanifibranor (IVA337) / Inventiva
    Review, Journal:  Current Clinical Trial Status and Future Prospects of PPAR-Targeted Drugs for Treating Nonalcoholic Fatty Liver Disease. (Pubmed Central) -  Aug 30, 2023   
    In addition, we summarize our recent findings on the binding modes and the potencies/efficacies of several candidate PPAR dual/pan agonists to estimate their therapeutic potentials against NASH. Considering that the development of numerous PPAR dual/pan agonists has been abandoned because of their serious side effects, we also propose a repositioning of the already approved, safety-proven PPAR-targeted drugs against NAFLD/NASH.
  • ||||||||||  Review, Journal:  An integrated view of anti-inflammatory and antifibrotic targets for the treatment of NASH. (Pubmed Central) -  Jul 18, 2023   
    Extrahepatic inflammatory signals from the circulation, adipose tissue or gut are targets of hormonal agonists (semaglutide, tirzepatide, FGF19/FGF21 analogues), microbiota or lifestyle interventions...In advanced fibrosis, cell therapy with restorative macrophages or reprogrammed T-cells (e.g., CAR T) may accelerate repair through HSC deactivation or killing, or by enhancing matrix degradation. Heterogeneity of disease - either due to genetics or divergent disease drivers - is an obstacle to defining effective drugs for all patients with NASH that will be incrementally overcome.
  • ||||||||||  lanifibranor (IVA337) / Inventiva, Hepalys Pharma
    Trial completion date, Trial primary completion date:  Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease (clinicaltrials.gov) -  Jun 9, 2023   
    P2,  N=54, Recruiting, 
    Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Nov 2023 Trial completion date: Apr 2023 --> Apr 2024 | Trial primary completion date: Apr 2023 --> Apr 2024