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NEWS
Galmed publishes Results from Aramchol Phase 3 Open Label part in Hepatology
• 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.
Previously, Galmed reported results from the Open-Label part of its Phase 3 NASH study, which demonstrated that treatment with Aramchol 300mg BID resulted in a high rate of subjects with histological fibrosis improvement.
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.
• 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.
Previously, Galmed reported results from the Open-Label part of its Phase 3 NASH study, which demonstrated that treatment with Aramchol 300mg BID resulted in a high rate of subjects with histological fibrosis improvement.
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.
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