Galmed Secures Global Patent Protection for Aramchol-Rezdiffra Combination Therapy in MASH Treatment
Key Insights
Galmed Pharmaceuticals has received a new use patent in South Korea for the combination of Aramchol and Madrigal's Rezdiffra (resmetirom) to treat metabolic dysfunction-associated steatohepatitis (search) (MASH (search)) and liver fibrosis (search).
The patent extends Aramchol's global intellectual property protection until July 2042, building on previous patents granted in the United States, Europe, Canada, and other jurisdictions.
Aramchol is positioned as a first-in-class, Phase 3-ready drug candidate with demonstrated robust fibrosis improvement in advanced clinical studies and excellent safety profile.
Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) announced the grant of a new use patent in South Korea covering the combination therapy of its lead compound Aramchol with Madrigal Pharmaceuticals' Rezdiffra (resmetirom) for treating metabolic dysfunction-associated steatohepatitis (search) (MASH (search)) and liver fibrosis (search). The patent strengthens Galmed's global intellectual property portfolio and extends protection until July 2042.
Expanding Global Patent Portfolio
The South Korean patent adds to an existing portfolio of patents already granted by the United States Patent and Trademark Office (USPTO), Europe, Canada, and other jurisdictions. This comprehensive patent protection positions Galmed to lead the development of combination therapies in the MASH (search) treatment landscape.
Aramchol is described as a first-in-class, Phase 3-ready drug candidate that has demonstrated robust fibrosis improvement in advanced clinical studies. The compound's excellent safety and tolerability profile makes it an ideal candidate for combination with other MASH (search) drugs, whether approved or in development.
Strategic Timing in MASH Treatment Evolution
"This patent grant comes at a pivotal moment in the NASH (search)/MASH (search) field, as the industry shifts toward combination therapies to address this complex disease," said Allen Baharaff, CEO of Galmed Pharmaceuticals. "As commercial interest in MASH is surging, with the limited mild to moderate efficacy demonstrated by monotherapies, initiation of combination MASH clinical studies is necessary and imminent."
Baharaff emphasized that Aramchol's safety profile positions it as a perfect candidate for combination with other MASH (search) therapeutics. "The grant of the Aramchol – Rezdiffra new patent is an important step towards the advancement in this direction," he added.
Company Focus and Development Strategy
Galmed operates as a clinical-stage biopharmaceutical company focused on liver, cardiometabolic diseases, and gastrointestinal oncological therapeutics. The company has concentrated almost exclusively on developing Aramchol for liver diseases and continues to actively advance the compound for combination therapy in MASH (search) treatment.
Beyond MASH (search) applications, Galmed is exploring Aramchol's potential in certain oncological indications. As part of its growth strategy, the company is pursuing opportunities to expand and diversify its product pipeline, specifically targeting cardiometabolic indications and other innovative product candidates that align with its core drug development expertise.
Combination Therapy Approach
The patent covers the use of Aramchol in combination with Rezdiffra (MGL-3196, resmetirom) for treating non-alcoholic steatohepatitis (search) (NASH (search)), also known as MASH (search), and liver fibrosis (search). This combination approach reflects the industry's recognition that complex diseases like MASH may require multi-target therapeutic strategies to achieve meaningful clinical outcomes.
The intellectual property protection extends Aramchol's patent coverage worldwide through July 2042, providing substantial commercial runway for the development and potential commercialization of this combination therapy approach in the evolving MASH (search) treatment market.