Policy & Regulation
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin
18 November 2025 -

Clinical-stage biopharmaceutical company Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) on Monday announced results from its joint research with Virginia Commonwealth University (VCU) evaluating Aramchol's effect on overcoming drug resistance in gastrointestinal (GI) cancers.

The collaboration is based on breakthrough findings published in Nature Communications.

Galmed reported in May 2025 that Aramchol significantly enhances the effect of Bayer's Stivarga (regorafenib) in GI cancer models to kill GI tumour cells. In that study, Aramchol enhanced both flux and autolysosome formation caused by regorafenib, activating ATM and AMPK and inactivating mTORC1 and mTORC2 pathways. In addition, regorafenib and Aramchol interacted to suppress tumour growth in hepatoma models without normal tissue toxicities.

The latest topline results include new data on the synergetic effects of Aramchol and Stivarga with type 2 diabetes drug metformin. This study demonstrated the mechanism of action of Aramchol's anti-tumour abilities, alone or when combined with the mutli-kinase inhibitor regorafenib and metformin, suggesting a synergistic effect and potential for fixed dose combination for treatment.

Metformin is typically the first-choice treatment for managing type 2 diabetes and is widely available in generic forms.

The combination of Aramchol and Stivarga is expected to enter phase 1b clinical trials early 2026 in metastatic colorectal cancer (CRC), hepatocellular (HCC), and cholangiocarcinoma patients with a planned expansion cohort including metformin.

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