The paper re-iterates the significant anti-fibrotic effect of Aramchol 300mg BID in patients with metabolic dysfunction associated steatohepatitis (MASH)
Data is confirmed using 3 objective measurements; NASH CRN, paired ranked reading, and Artificial Intelligence (AI) quantitative digital analysis
Continuous histological fibrosis scores generated in antifibrotic trials by digital pathology images analysis (DIA) quantify antifibrotic effects with greater sensitivity and larger dynamic range than Conventional Pathology
TEL AVIV, Israel, Sept. 25, 2024 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibro-inflammatory diseases announced today that the one-year results of the Open-Label part (ARCON ) of its global Phase 3 trial of Aramchol in 150 patients with NASH and fibrosis (ARMOR) have been published in Hepatology.
Aramchol is the most advanced down regulator of SCD-1 (Stearoyl – CoA desaturase) in clinical development. Inhibition of SCD-1 has been recently investigated in multiple indications, re-emphasizing its metabolic master switch potential and importance in multiple organs and activities. Aramchol, by targeting this single receptor, induces a cascade of events that leads to two main changes; in hepatocytes, Aramchol elevates the fatty acids oxidation (or in other words – fat burn) and influences AMPK, which results also in reducing glycemic parameters; and in hepatic stellate cells, Aramchol has been shown to down-regulate the expression and activity of stearoyl-CoA desaturase-1 (SCD-1), resulting in a direct effect on fibrogenesis.
Galmed has long believed that the optimum treatment for MASH will be combination therapy. The company further believes that Aramchol' s unique mechanism of action differentiates itself from others in the competitive landscape, potentially positioning it to work as a potent anti-fibrotic compound alongside effective treatments in both approved and pre-approval stages.
Prof. Vlad Ratziu, Professor of Hepatology, Sorbonne Université, the paper's lead author and the ARMOR study co-principal investigator commented: "The publication of the results of the ARCON cohort in a prestigious medical journal such as Hepatology speaks to the interest of the scientific community towards this molecule with an innovative mode of action and its potential for treating fibrotic MASH. The rigorous multimodality histology assessment, using both conventional and FibroNest™ AI digital pathology (PharmaNest Inc, Princeton, USA), allowed us to see that the drug was working and identify changes of regression as well as affirming and extending findings of the AI Digital Pathology analysis that is relevant to all MASH studies."
"The publication in Hepatology highlights the significant potential of Aramchol as a therapeutic option for patients diagnosed with MASH and Fibrosis. We are grateful to all the patients and clinical sites that participated in the study around the world. Our sincere thanks to Prof. Vlad Ratziu, Prof. Arun Sanyal the study co-PIs, and Prof. Scott Friedman for their fruitful scientific and clinical guidance. We also extend our gratitude to Prof. Carolin Lackner, Prof. Cynthia Behling and Prof. William Cummings, the study pathologists for their meticulous reading and interest in exploring the benefits of Digital Pathology and Artificial intelligence in the context of MASH clinical trials", said Allen Baharaff, President and Chief Executive Officer of Galmed.
About Galmed Pharmaceuticals Ltd.
We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver disease and have been developing Aramchol for PSC and exploring the feasibility of developing Aramchol for other fibroinflammatory and oncological indications outside of liver disease. We are also collaborating with the Hebrew University in the development of Amilo5MER, a 5 amino acid synthetic peptide.
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