By: IPP Bureau
Last updated : November 18, 2025 12:56 pm
Stivarga is the standard third-line treatment for metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma
Galmed Pharmaceuticals, a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and GI oncology therapeutics, announced groundbreaking new findings from its collaboration with Virginia Commonwealth University (VCU).
The joint research demonstrates that Galmed’s Aramchol could help overcome drug resistance in gastrointestinal (GI) cancers, building on prior discoveries published in Nature Communications.
Earlier in May 2025, Galmed revealed that Aramchol significantly enhanced the effect of Bayer’s top-selling cancer drug, regorafenib (Stivarga), in preclinical GI cancer models. Aramchol boosted both flux and autolysosome formation triggered by regorafenib, activating ATM and AMPK pathways while shutting down mTORC1 and mTORC2 pathways. Together, the drugs suppressed tumor growth in hepatoma models without harming normal tissue.
The latest study extends these findings, showing that Aramchol also works synergistically with regorafenib and the diabetes drug Metformin, hinting at the potential for a fixed-dose combination therapy for GI cancers.
"Stivarga is the standard third-line treatment for metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma,” said Allen Baharaff, Galmed President and CEO. “Yet around 75% of patients develop resistance or intolerance to first-line monoclonal antibody therapies, and high costs limit accessibility. Aramchol’s combination potential could be a game-changer.”
Bayer’s regorafenib generated €458 million (~$500 million) in the first nine months of 2022, up 28% from 2021. With main patent protections expiring in Europe in 2028 and the US in 2032, generics could soon enter the market. Baharaff noted that a fixed-dose combination with Aramchol could extend the drug’s lifecycle and delay generic competition.
Galmed plans to launch a Phase 1b clinical trial at VCU Massey Comprehensive Cancer Center in early 2026. The trial will serve as proof-of-concept for Aramchol’s efficacy in oncology and, if successful, could accelerate clinical development across three major GI cancers, potentially expanding Galmed’s pipeline and creating significant value for investors.