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  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  Farnesoid X receptor and bile acids regulate vitamin A storage. (Pubmed Central) -  Nov 12, 2020   
    Obeticholic acid (OCA, 3 weeks) treatment rapidly reduced (>60%) hepatic retinyl palmitate levels in mice, concurrent with strongly increased retinol levels (>5-fold)...OCA did not change hepatic LRAT protein levels, but strongly reduced all enzymes involved in hepatic retinyl ester hydrolysis, involving mostly post-transcriptional mechanisms. In conclusion, vitamin A metabolism in the mouse liver heavily depends on the FXR and FXR-targeted therapies may be prone to cause vitamin A-related pathologies.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Trial completion date, Trial primary completion date:  Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients (clinicaltrials.gov) -  Nov 12, 2020   
    P2,  N=20, Recruiting, 
    In conclusion, vitamin A metabolism in the mouse liver heavily depends on the FXR and FXR-targeted therapies may be prone to cause vitamin A-related pathologies. Trial completion date: Dec 2020 --> Jun 2021 | Trial primary completion date: Sep 2020 --> May 2021
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Trial completion date, Trial primary completion date:  Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT (clinicaltrials.gov) -  Nov 10, 2020   
    P=N/A,  N=70, Recruiting, 
    Trial completion date: Dec 2020 --> Jun 2021 | Trial primary completion date: Sep 2020 --> May 2021 Trial completion date: Aug 2020 --> Dec 2020 | Trial primary completion date: Aug 2020 --> Nov 2020
  • ||||||||||  Journal:  Current and emerging pharmacological options for the treatment of nonalcoholic steatohepatitis. (Pubmed Central) -  Nov 3, 2020   
    Whether these and other medications could offer tangible therapeutic benefits, alone or in combination, apparently on a background of lifestyle modification, i.e. exercise and a healthy dietary pattern e.g. Mediterranean diet remains to be proven. In conclusion, major advances are expected for the treatment of NASH.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Journal:  Autoimmune mediated cholestatic liver diseases (Pubmed Central) -  Nov 2, 2020   
    The only approved second line therapy is obeticholic acid (OCA)...Disease management should address compromising symptoms like pruritus and sicca as well as complications due to maldigestion and concomitant autoimmune diseases. The only curative treatment available is liver transplantation and should be considered at a MELD score of 15.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Review, Journal:  Obeticholic acid for primary biliary cholangitis. (Pubmed Central) -  Oct 26, 2020   
    This robust phase 3 study assesses the effect of OCA on liver histology as a surrogate for transplant-free survival and liver-related outcomes, including progression to cirrhosis and mortality, and will ultimately assess clinical benefit through specific evaluation of these outcomes (ClinicalTrials.gov, NCT02548351). No abstract available
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    Preclinical, Journal:  Obeticholic acid improves fetal bile acid profile in a mouse model of gestational hypercholanemia. (Pubmed Central) -  Oct 24, 2020   
    In conclusion, OCA administration during gestation had no apparent detrimental impact on maternal or fetal morphometry and improved fetal hypercholanemia. As high serum bile acid concentrations in ICP are associated with increased rates of adverse fetal outcomes, further investigations into the potential use of OCA during cholestatic gestation are warranted.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    [VIRTUAL] LONG-TERM BENEFITS OF OBETICHOLIC ACID IN NONALCOHOLIC STEATOSIS PATIENTS: A MODELING STUDY () -  Oct 11, 2020 - Abstract #AASLD2020AASLD_1607;    
    The present study provides one of the first predictive models on the long-term outcomes of obeticholic acid in NASH patients. We project that that the responders of the REGENERATE trial could experience substantial long-term reduction in the risk of advanced liver disease and mortality, with higher benefits in NASH F3 patients than F2.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    [VIRTUAL] REAL WORLD CLINICAL MANAGEMENT OF PATIENTS WITH PRIMARY BILIARY CHOLANGITIS - A RETROSPECTIVE MULTICENTER STUDY FROM GERMANY () -  Oct 11, 2020 - Abstract #AASLD2020AASLD_1266;    
    Second-line treatment regimens for patients with inadequate response to UDCA at 12 months, which included UDCA dosage intensification respectively addition of glucocorticoids, fibrates or obeticholic acid, and subsequent response rates at 12 months were also evaluated... Our large retrospective multicenter study highlights the need for close monitoring and early treatment modification in patients with PBC and inadequate UDCA treatment response.
  • ||||||||||  [VIRTUAL] HUMAN IN VITRO 3D NASH MODEL FOR HIGH-THROUGHPUT DRUG EFFICACY TESTING () -  Oct 11, 2020 - Abstract #AASLD2020AASLD_546;    
    Importantly, treatment with anti-NASH drug candidates (Elafibranor, Obeticholic acid, Selonsertib and Firsocostat) affected biochemical endpoints indicative of disease progression and the results were to a large extent in line with clinical observations. In summary, using this 3D NASH model to test novel drug candidates in pre-clinical and clinical development represents a promising approach for selection and decision making of the most effective drug candidates to move further in the development.
  • ||||||||||  Previfenon (epigallocatechin gallate) / MELISA Institute, Ocaliva (obeticholic acid) / Intercept
    [VIRTUAL] ELEVATED EXPRESSION OF NA+/TAUROCHOLATE CO-TRANSPORTING POLYPEPTIDE ON HEPATIC STELLATE CELLS IN LIVER FIBROSIS () -  Oct 11, 2020 - Abstract #AASLD2020AASLD_312;    
    In vitro: NTCP expression on the LX2 human-hepatic stellate cell line was modulated with NTCP-siRNA, taurocholic acid (TCA, NTCP physiological substrate), obeticholic acid (OCA, NTCP antagonist and Farnesoid X receptor (FXR) agonist), epigallocatechin gallate (EGCG, NTCP degrading agent) and HA-100 di-hydrochloride (HA-100, PKC inhibitor). Antagonizing NTCP through decreasing its expression and translocation may be an important therapeutic strategy for preventing disease progression.
  • ||||||||||  Ocaliva (obeticholic acid) / Intercept
    [VIRTUAL] OBETICHOLIC ACID AS A POTENTIAL TREATMENT STRATEGY TO PREVENT HIV- AND ALCOHOL-INDUCED LIVER FIBROSIS () -  Oct 11, 2020 - Abstract #AASLD2020AASLD_265;    
    Antagonizing NTCP through decreasing its expression and translocation may be an important therapeutic strategy for preventing disease progression. We conclude that our in vitro study provides mechanistic evidence for the benefits of including OCA to the treatment scheme for HIV-infected alcohol abusers with a high risk of progression to liver fibrosis.
  • ||||||||||  low molecular weight dextran sulfate (ILB) / TikoMed, Ocaliva (obeticholic acid) / Intercept
    [VIRTUAL] STAT3 SIGNALING MAY MEDIATE PROTECTIVE EFFECT OF FXR AGONIST IN PARENTERAL NUTRITION ASSOCIATED CHOLESTASIS () -  Oct 11, 2020 - Abstract #AASLD2020AASLD_65;    
    HepG2 cells and PNAC mouse model (treatment with oral dextran sulfate sodium [DSS] for 4 days followed by total PN for 14 days = DSS-PN mice [Nat Commun... These data demonstrate a previously undescribed mechanism, induction of STAT3 signaling, by which FXR agonists may be hepatoprotective in PNAC, and possibly other cholestatic liver diseases.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, Lacromid (bezafibrate) / Remedica
    Clinical, Journal:  Additional fibrate treatment in UDCA-refractory PBC patients. (Pubmed Central) -  Oct 11, 2020   
    These data demonstrate a previously undescribed mechanism, induction of STAT3 signaling, by which FXR agonists may be hepatoprotective in PNAC, and possibly other cholestatic liver diseases. In patients with UDCA-refractory PBC, additional fibrate treatment is associated with a higher probability of ALP normalization and a lower risk of cirrhosis development and hepatic deterioration.