Here is a summary of recent news about Aramchol:
- New Patent Granted: Galmed Pharmaceuticals announced the grant of a new patent related to the use of a combination of Aramchol and Resmetirom (MGL-3196, REZDIFFRA) for the treatment of NASH/MASH and liver fibrosis. This patent was granted in France, Germany, Italy, the Netherlands, and the United Kingdom, with the approval in the United States and other countries pending1.
- Expansion of Clinical Development: Galmed has decided to expand the clinical development of Aramchol to additional indications, aiming to maximize the potential of the lead compound. This strategy change is based on positive results from the first part of the ARMOR study, showing a consistent antifibrotic effect, and the timing of the initiation of the Double-Blind Part with the improved formulation of Aramchol Meglumine2.
- Significant Anti-Fibrotic Effects in Pre-Clinical Models: Galmed reported statistically significant clinical and histology improvements in a model of inflammatory bowel disease (IBD), demonstrating the potential of Aramchol as a treatment for fibrosis in various organ systems3.
- Interim Results from the Open-Label Part of the ARMOR Study: The Open-Label Part of the ARMOR study with Aramchol showed robust fibrosis improvement across multimodality histological assessment, indicating the effectiveness of the treatment in NASH patients4.
- Phase 2 Data: The Phase 2b data from the ARREST study identified Aramchol 600mg as potentially effective in resolving NASH and improving fibrosis. These results favor further testing in a Phase 3 trial and were selected for "The Best of The Liver Meeting 2018"5.
In summary, Aramchol has shown promising results in various pre-clinical and clinical studies, demonstrating its potential as a treatment for fibrosis in different organ systems. The recent expansion of clinical development to additional indications, based on the positive results from the ARMOR study, is a strategic move to maximize the potential of the compound.