GLMD News & Events

Galmed Pharmaceuticals and Tissue Dynamics announced a collaboration to develop a novel human chronic cardiac fibrosis model designed to accelerate the discovery and development of new Aramchol-based therapeutic approaches for complex fibrotic heart diseases. Cardiac fibrosis is a major driver of chronic heart failure. There are no approved therapies that directly and durably reverse cardiac fibrosis. Regulators are now explicitly encouraging more human-relevant approaches. Tissue Dynamics and Galmed are collaborating on the development of the new platform as a high-throughput, human-centered model of chronic cardiac fibrosis, with an initial focus on the long-term effects of myocardial infarction and the fibrotic-metabolic remodeling associated with HFpEF. The platform will combine Tissue Dynamics' highly physiological vascularized, multichambered cardiac organoids with embedded metabolic sensors, massive automation, and continuous real-time monitoring. Tissue Dynamics is a next-generation human-focused CRO delivering predictive preclinical data using human organoid systems, real-time metabolic analytics, and explainable AI. Galmed aims to use this platform to develop and investigate new Aramchol-based therapies for chronic cardiac fibrotic disease.

Galmed Pharmaceuticals announced a research collaboration agreement with Ramot at Tel Aviv University to evaluate Galmed's brain-penetrating SCD1 inhibitor, Aramchol, as a targeted therapy for metastatic brain cancer. By combining the genomic expertise of the Ben-David Lab with the advanced 3D in vitro and in vivo modeling capabilities of the Satchi-Fainaro Lab, Galmed aims to validate Aramchol's efficacy in treating p53-deficient brain metastases. The findings from the new research would also support Galmed's clinical work underway at Virginia Commonwealth University's Massey Comprehensive Cancer Center in colorectal cancers, where p53 mutations are highly prevalent. The published research by Prof. Ben-David and Prof. Satchi-Fainaro demonstrated that the loss of p53 induces profound metabolic adaptations of the tumor, facilitating metastatic colonization in the lipid-rich brain microenvironment. SCD1, an enzyme that converts saturated fatty acids into monounsaturated fatty acids, is essential for lipid synthesis and membrane production in proliferating cancer cells. Owing to SCD1 upregulation in p53-deficient tumors, its downregulation by Aramchol could potentially treat the metabolic-dependent brain tumor, as confirmed in preclinical models. The collaboration is managed by Ramot, Tel Aviv University's technology transfer company. Ramot is dedicated to bringing the groundbreaking research of Prof. Uri Ben-David and Prof. Ronit Satchi-Fainaro to the clinic. Their work on the metabolic vulnerabilities of p53-deficient tumors represents a transformative approach to treating metastatic brain cancer, offering a new path for patients with high unmet needs.

Galmed announced the breakthrough development of a brain penetrating new formulation of Aramchol. Crossing of the blood-brain barrier, or BBB, is an essential step to achieve effective treatment effects in Parkinson disease and other CNS diseases. The new Aramchol formulation is characterized by sequestration of the Aramchol in lipid nanoparticles which will be administered by subcutaneous injection for delivery across the BBB. This new Aramchol formulation was co-developed by Galmed and Barcode Nanotech, based on Barcode Nanotech's proprietary platform. Galmed's medicinal chemistry work converting Aramchol into a brain-penetrant SCD1 inhibitor position Aramchol as a therapeutic asset for synucleinopathies such as Parkinson disease, multiple systems atrophy, dementia and other CNS indications of unmet need.

Galmed announced the grant of a new Use Patent related to its lead compound, Aramchol. The patent covers the use of a combination therapy of Aramchol and Rezdiffra for the treatment of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and liver fibrosis in South Korea. Previously, Galmed announced the grant of new use patent for a combination of Aramchol and Madrigal Pharmaceuticals' Rezdiffra for MASH. The new patent extends Aramchol's patent protection worldwide to July 2042.