Galmed Pharmaceuticals Ltd. has announced the publication of one-year results from the Open-Label part (ARCON) of its global Phase 3 trial of Aramchol in 150 patients with NASH and fibrosis (ARMOR) in Hepatology. The study re-iterates the significant anti-fibrotic effect of Aramchol 300mg BID in patients with metabolic dysfunction-associated steatohepatitis (MASH).
Multimodality Histological Assessment
The data confirming Aramchol's efficacy was obtained using three 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.
Previously reported results from the Open-Label part of the Phase 3 NASH study demonstrated that treatment with Aramchol 300mg BID resulted in a high rate of subjects with histological fibrosis improvement.
Aramchol's Mechanism of Action
Aramchol is described as 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. By targeting this single receptor, Aramchol induces a cascade of events leading to two main changes: in hepatocytes, Aramchol elevates fatty acids oxidation (fat burn) and influences AMPK, reducing glycemic parameters; and in hepatic stellate cells, Aramchol down-regulates the expression and activity of stearoyl-CoA desaturase-1 (SCD-1), directly impacting fibrogenesis.
Potential for Combination Therapy
Galmed believes that the optimum treatment for MASH will be combination therapy and 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.
Expert Commentary
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."
Allen Baharaff, President and Chief Executive Officer of Galmed, stated: "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."
