GLMD News & Events

Galmed announced milestone results from a Phase 1 PK study in healthy subjects. The overall objective of the study was to identify the dose of Aramchol meglumine - AM - administered once daily that produces similar exposure to Aramchol from 300mg Aramchol free acid - AA - tablets dosed twice daily. Single doses of AM granules for oral suspension of 400 mg and 200mg were evaluated and compared to AA 300mg tablet. The study demonstrated that the bioavailability of Aramchol from the Aramchol meglumine granules for oral suspension is considerably greater than that from Aramchol free acid tablets. An additional PK study comparing AM 400mg tablets once daily with AA 300mg tablets twice daily is ongoing. In Phase 2 and Phase 3 clinical trials 600mg Aramchol reduced liver fat, attenuated steatohepatitis and demonstrated robust anti-fibrotic effects. MASH, previously called non-alcoholic steatohepatitis or NASH, is a common serious type of fatty liver disease often leading to cirrhosis, liver failure and sometimes to hepatocellular carcinoma. To date ~ 600 adults have received single or multiple doses of Aramchol free acid, including ~240 healthy subjects and 360 patients with MASH.

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.