Aramchol (aramchol meglumine) / Galmed 
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 23 Diseases   1 Trial   1 Trial   117 News 


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  • ||||||||||  Aramchol (aramchol meglumine) / Galmed
    POTENTIAL USE OF IPSC-DERIVED HEPATOCYTE-LIKE CELLS TO DEVELOP PRECISION MEDICINE FOR ASH () -  Oct 15, 2024 - Abstract #AASLD2024AASLD_2156;    
    In vitro exposure of iHLCs to ethanol induced lipid accumulation and upregulated fatty acid synthesis pathways. iHLCs were also generated from ASH patients' blood samples and their further characterization may facilitate the development of precision therapeutics.
  • ||||||||||  Aramchol (aramchol meglumine) / Galmed
    Trial completion date, Trial suspension, Trial primary completion date:  A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis (clinicaltrials.gov) -  Sep 19, 2024   
    P2,  N=24, Suspended, 
    iHLCs were also generated from ASH patients' blood samples and their further characterization may facilitate the development of precision therapeutics. Trial completion date: Dec 2026 --> Dec 2027 | Not yet recruiting --> Suspended | Trial primary completion date: Sep 2025 --> Sep 2026
  • ||||||||||  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.
  • ||||||||||  Bridging the gap - (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_694;    
    Recently we validated our advanced MPS NASH model using two anti-NASH compounds, Obeticholic acid and Elafibranor...Selonsertib showed no antifibrotic or anti-inflammatory effects in our MPS NASH model at clinically relevant dosage, matching results from phase III STELLAR trials, despite reduced fibrosis and inflammation being detected in alternative 3D spheroid models. Overall, we demonstrate how this NASH liver MPS provides translatable insights into drug efficacy for NASH therapeutics and brings a promising, sensitive alternative for pre-clinical NASH screening to help fast-track decision making and access to the market.
  • ||||||||||  Aramchol (aramchol meglumine) / Galmed
    Trial suspension:  A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR) (clinicaltrials.gov) -  Aug 4, 2022   
    P3,  N=2000, Suspended, 
    Overall, we demonstrate how this NASH liver MPS provides translatable insights into drug efficacy for NASH therapeutics and brings a promising, sensitive alternative for pre-clinical NASH screening to help fast-track decision making and access to the market. Recruiting --> Suspended
  • ||||||||||  Aramchol (arachidyl amido cholanoic acid) / Galmed, Weizmann Institute of Science
    Journal:  Blockage of NDUFB9-SCD1 pathway inhibits adipogenesis : Blockage of NDUFB9-SCD1 pathway inhibits adipogenesis. (Pubmed Central) -  Jul 2, 2022   
    The effect of Ndufb9 is mediated through stearoyl-CoA desaturase 1 (Scd1). Aramchol, a SCD1 inhibitor, significantly blocks adipogenesis (markedly TG decrease, p < 0.001).Our study broadens the understanding of the role of Ndufb9 in adipogenesis and provides a new target for the treatment of NAFLD.
  • ||||||||||  Aramchol (arachidyl amido cholanoic acid) / Galmed, Weizmann Institute of Science
    Higher daily Aramchol dose results in higher effect size in fibrosis improvement in the ARMOR study open label part (Poster Area) -  Mar 16, 2022 - Abstract #EASLILC2022EASL_ILC_1125;    
    Data is corroborated by congruent changes in fibrosis biomarkers and by a biochemical response in aminotransferases. The data presented here, albeit preliminary, is aligned with the hypothesis that higher Aramchol exposure results in an improved efficacy profile and a direct anti-fibrotic effect may be manifested as early as 24 weeks.
  • ||||||||||  Aramchol (arachidyl amido cholanoic acid) / Galmed, Weizmann Institute of Science
    HIGHER DAILY ARAMCHOL DOSE RESULTS IN HIGHER EFFECT SIZE IN FIBROSIS IMPROVEMENT IN THE ARMOR STUDY OPEN LABEL PART () -  Mar 3, 2022 - Abstract #NASHTAG2022NASH_TAG_97;    
    Data is corroborated by congruent changes in fibrosis biomarkers and by a biochemical response in aminotransferases. The data presented here, albeit preliminary, is aligned with the hypothesis that higher Aramchol exposure results in an improved efficacy profile and that a direct anti-fibrotic effect may be manifested as early as 24 weeks.
  • ||||||||||  Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
    Clinical, Review, Journal:  Non-Alcoholic Steatohepatitis (NASH) - A Review of a Crowded Clinical Landscape, Driven by a Complex Disease. (Pubmed Central) -  Feb 2, 2022   
    At the time of writing this review, only Zydus Cadila's new drug application for Saroglitazar had been approved (2020) for NASH therapy in India...Obeticholic acid (Intercept Pharmaceuticals), Cenicriviroc (Allergan), Aramchol (Galmed Pharmaceuticals), Resmetirom (Madrigal Pharmaceuticals), Dapagliflozin and Semaglutide (Novo Nordisk) are in advanced Phase 3 clinical trials, while Belapectin (Galectin Therapeutics), MSDC-0602K (Cirius Therapeutics), Lanifibranor (Inventiva), Efruxifermin (Akero) and Tesamorelin (Theratechnologies) are expected to start Phase 3 trials soon...Hence, the development of a single therapy for NASH seems challenging and unlikely, despite the plethora of later stage trials due to report. We therefore predict that clinical, patient and company interest in pipeline and next-generation therapies will remain high for some time to come.
  • ||||||||||  Aramchol (arachidyl amido cholanoic acid) / Galmed, Weizmann Institute of Science
    Clinical, P2b data, Journal:  Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial. (Pubmed Central) -  Nov 17, 2021   
    P2b
    Early termination due to adverse events (AEs) was <5%, and Aramchol 600 and 400 mg were safe, well tolerated and without imbalance in serious or severe AEs between arms. Although the primary end point of a reduction in liver fat did not meet the prespecified significance level with Aramchol 600 mg, the observed safety and changes in liver histology and enzymes provide a rationale for SCD1 modulation as a promising therapy for NASH and fibrosis and are being evaluated in an ongoing phase 3 program.
  • ||||||||||  Aramchol (arachidyl amido cholanoic acid) / Galmed, Weizmann Institute of Science, resmetirom (MGL-3196) / Madrigal Pharma, lanifibranor (IVA337) / Inventiva
    [VIRTUAL] PHYSICIAN AWARENESS OF AND PREFERENCES FOR COMBINATION THERAPY FOR NAFLD/NASH TREATMENT () -  Oct 21, 2021 - Abstract #AASLD2021AASLD_2152;    
    Nevertheless, the stages of NAFLD/NASH suggest that treating multiple facets of the disease may be required . Hepatologists appear more aware and accepting than gastroenterologists of the potential for combination therapy in NAFLD/NASH .
  • ||||||||||  Egrifta (tesamorelin acetate) / Theratechnologies, Massachusetts General Hospital, Aramchol (arachidyl amido cholanoic acid) / Galmed, Weizmann Institute of Science
    [VIRTUAL] TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS- ASSOCIATED NON-ALCOHOLIC FATTY LIVER DISEASE – A SYSTEMATIC REVIEW () -  Oct 21, 2021 - Abstract #AASLD2021AASLD_2116;    
    The available data suggest improvement in liver fat content as measured by MRI-PDFF with Tesamorelin . Given the prevalence, risk factors, and inability to generalize data to the HIV population, more studies need to be done for patients with HIV-associated NAFLD .
  • ||||||||||  Clinical, Review, Journal:  Efficacy and safety of drugs for nonalcoholic steatohepatitis. (Pubmed Central) -  Sep 19, 2021   
    Vitamin E has been recommended for patients with NASH without type 2 diabetes mellitus (T2DM), whereas a combination of pioglitazone and vitamin E is recommended for patients with both NASH and T2DM...Some of the drugs are at phase III clinical trials, including obeticholic acid (OCA), Elafibranor, Cenicriviroc, Selonsertib, Resmetirom, Emricasan and Aramchol...Especially, due to the interim positive effect for the improvement of liver fibrosis, OCA has been filling to FDA and is waiting for the final approval for the treatment of NASH. Therefore, it is urgent to review the efficacy and safety of drugs for NASH in current clinical trials.
  • ||||||||||  Journal:  Nonalcoholic Fatty Liver Disease: A Drug Revolution Is Coming. (Pubmed Central) -  Sep 11, 2021   
    Five pharmacologic agents-obeticholic acid, elafibranor, cenicriviroc, resmetirom, and aramchol-are being evaluated in large, histology-based phase 3 trials...Based on the results of phase 2 and 3 trials, combination treatments are also being investigated. Future treatment strategies will comprise drug combinations and precision medicine based on the different phenotypes of NASH and treatment response of the individual patient.
  • ||||||||||  Journal:  New drugs for non-alcoholic steatohepatitis and HIV infection: great expectations with a great absent? (Pubmed Central) -  Apr 21, 2021   
    The risk of DDI between ART and aramchol, cenicriviroc, elafibranor, obeticholic acid and resmetirom (MGL-3196), which are currently in phase III trials for the treatment of NASH, are reviewed. Finally, a model for trial design to include PLWH is proposed, strongly advocating for the scientific community to include this group as a sub-population within studies.
  • ||||||||||  Aramchol (aramchol meglumine) / Galmed
    Trial completion date, Trial primary completion date:  A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR) (clinicaltrials.gov) -  Feb 17, 2021   
    P3,  N=2000, Recruiting, 
    Galmed intends to target the desired exposure of Aramchol 300 mg BID currently used in the open label part of ARMOR. Trial completion date: Dec 2024 --> Jun 2027 | Trial primary completion date: Jun 2022 --> Dec 2024
  • ||||||||||  Aramchol (aramchol meglumine) / Galmed
    Trial completion date, Trial primary completion date:  Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment (clinicaltrials.gov) -  Feb 9, 2021   
    P1,  N=56, Enrolling by invitation, 
    Trial completion date: Dec 2024 --> Jun 2027 | Trial primary completion date: Jun 2022 --> Dec 2024 Trial completion date: Jan 2021 --> Jul 2021 | Trial primary completion date: Dec 2020 --> Jun 2021
  • ||||||||||  [VIRTUAL] Non-Alcoholic Steatohepatitis (NASH) Drug Pipeline Report September 2020 () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_2853;    
    Due to the complexity of NASH pathophysiology, whether combinations of drugs may improve efficacy over single agents still remains to be studied. Currently available non-histological biomarkers have not consistently shown enough correlation to replace histological endpoints within clinical trials.
  • ||||||||||  Aramchol (arachidyl amido cholanoic acid) / Galmed, Weizmann Institute of Science
    [VIRTUAL] Aramchol improves glucose and lipid homeostasis in NASH via regulation of AMPK and mTOR (Poster Area) -  May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-987;    
    Our study shows that hepatocytes respond to Aramchol treatment by activating AMPK and inhibiting mTORC1, which in turn activate FA β-oxidation and oxidative phosphorylation inhibiting de novo lipogenesis, gluconeogenesis and cataplerosis. These results offer a possible explanation for downregulation of HbA1c as well as for the reduction in hepatic TG observed in NASH patients treated with Aramchol.
  • ||||||||||  Review, Journal:  What is the (right) target for non-alcoholic fatty liver disease (NAFLD)? (Pubmed Central) -  Jan 22, 2020   
    A number of phase 3 clinical trials are currently ongoing including Elafibranor, a dual PPAR α/δ agonist, Cenicriviroc, a CCR2/CCR5 chemokine antagonist, the nuclear bile acid receptor FXR agonist obeticholic acid, Aramchol, a fatty acid bile acid conjugate that modulates SCD-1, and Resmetrion, a liver-specific THR-β agonist...the ASK-1 inhibitor Selonsertib or the caspase inhibitor Emricasan have shown negative results...The complex pathophysiology of the disease, which combines inflammation, metabolism and fibrosis, has led to the fact that even combinations of several substances are investigated with different modes of action. This review summarizes pivotal clinical trials for patients with NASH in the absence of cirrhosis which are recruiting in the fall of 2019.