GLMD News & Events

Galmed and Tissue Dynamics announced results from a preclinical study evaluating a combination of Aramchol Meglumine, an SCD1 inhibitor, and a selective PPARalpha agonist. The study identified a previously unrecognized metabolic pathway involved in the progression of cardiac fibrosis and heart failure and demonstrated that the two-drug combination effectively targets this mechanism. Progressive cardiac fibrosis, driven by ischemic injury or age-related metabolic dysfunction, results in pathological scarring of the heart muscle, leading to tissue stiffening and impaired systolic and diastolic function. Cardiac fibrosis is a major contributor to heart failure progression and remains an area of significant unmet medical need. The study demonstrated that a combination of Aramchol Meglumine and a selective PPARalpha agonist modulates two key pathological processes-mitochondrial stress and associated lipogenesis-that contribute to the development and progression of cardiac fibrosis and heart failure. In inflammatory human cardiac organoids, the treatment reduced fibrotic burden by approximately fourfold while preserving cardiac muscle density and maintaining metabolic function. Based on these findings, a new patent application has been filed, and preparations are underway to support future IND-enabling activities.

Galmed and Tissue Dynamics announced results from a preclinical study evaluating a combination of Aramchol Meglumine, an SCD1 inhibitor, and a selective PPARalpha agonist. The study identified a previously unrecognized metabolic pathway involved in the progression of cardiac fibrosis and heart failure and demonstrated that the two-drug combination effectively targets this mechanism. Progressive cardiac fibrosis, driven by ischemic injury or age-related metabolic dysfunction, results in pathological scarring of the heart muscle, leading to tissue stiffening and impaired systolic and diastolic function. Cardiac fibrosis is a major contributor to heart failure progression and remains an area of significant unmet medical need. The study demonstrated that a combination of Aramchol Meglumine and a selective PPARalpha agonist modulates two key pathological processes-mitochondrial stress and associated lipogenesis-that contribute to the development and progression of cardiac fibrosis and heart failure. In inflammatory human cardiac organoids, the treatment reduced fibrotic burden by approximately fourfold while preserving cardiac muscle density and maintaining metabolic function. Based on these findings, a new patent application has been filed, and preparations are underway to support future IND-enabling activities.

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.