Announcement • Jul 28
Galmed Pharmaceuticals Ltd. Announces Breakthrough Development Of Dispersible Film Delivery (ODF) Brain Penetrating Formulation Of Its SCD1 Inhibitor Aramchol For Parkinson's Disease Galmed Pharmaceuticals Ltd. had reported significant progress in development of new Aramchol orally dispersible film (ODF) formulation. Aramchol meglumine is the only SCD1 inhibitor with an established clinical safety profile and confirmed blood-brain barrier (BBB) penetration. In order to improve patient convenience and long-term treatment adherence by Parkinson patients affected by dysphagia, an ODF formulation was developed demonstrating ~150% higher systemic bioavailability and ~300% significant increase in CNS exposure than conventional oral administration. Aramchol's ODF is characterized by rapid buccal and sublingual absorption and reduced first-pass hepatic metabolism, designed to maximize drug exposure within the brain. The data demonstrate ~150% higher systemic bioavailability and ~300% significant increase in CNS exposure than conventional oral administration. In addition to enhancing CNS drug delivery, Aramchol's proprietary ODF formulation directly addresses one of the most common clinical challenges in Parkinson's disease (PD). Up to 80% of patients develop dysphagia during disease progression, making conventional tablets and liquid formulations increasingly difficult to swallow and contributing to poor treatment adherence. Aramchol's rapidly dissolving ODF formulation dissolves within seconds without water, eliminates the need to swallow conventional tablets or liquids, thus simplifying administration and possibly improving long-term treatment adherence. The inhibition of stearoyl-CoA desaturase 1 (SCD1) is a novel disease approach in Parkinson's Disease, that targets the cause of neurodegeneration. Growing evidence identifies SCD1 as a central regulator of lipid metabolism that contributes to a-synuclein aggregation, Lewy body formation, and neuronal dysfunction. Unlike currently approved therapies that primarily improve motor symptoms through dopaminergic replacement, Aramchol targets SCD1-related biological mechanisms associated with disease progression. As previously reported, Galmed's in-vitro data demonstrated that Aramchol dose-dependently down-regulated aSyn aggregation as well as indicating that the effect was not associated with toxicity. Galmed's ODF formulation of Aramchol represents a dual innovation: a mechanism-based approach to slowing disease progression combined with patient-friendly drug delivery that addresses dysphagia affecting Parkinson's patients. Galmed believes that the development of a clinically characterized SCD1 inhibitor with a CNS-optimized drug delivery formulation represents a differentiated strategy in a therapeutic area where disease-modifying treatment options remain limited, positioning Aramchol's PD program as an ideal out-licensing candidate. Announcement • Jul 23
Galmed Pharmaceuticals Ltd., Annual General Meeting, Aug 26, 2026 Galmed Pharmaceuticals Ltd., Annual General Meeting, Aug 26, 2026. Location: 16 abba hillel silver rd., ramat gan, 5250608., Israel Announcement • Jul 16
Galmed Pharmaceuticals Ltd. Develops Novel LNP Cardiac Targeted Formulation Of Aramchol Galmed Pharmaceuticals Ltd. has developed, in collaboration with Barcode Nanotech, a unique proprietary lipid nanoparticles (LPNs) novel formulation of Aramchol that penetrates the heart tissue and redirects Aramchol's biodistribution away from liver-hepatocytes to the heart's muscle. Cardiac fibrosis is a major driver of chronic heart failure, the leading cause of death globally, responsible for an estimated 20.5 million deaths in 2025. Aramchol's anti-fibrotic effects were demonstrated in the liver in a Phase 3 (open label part) MASH study as well as in human heart organoids and in-vivo lung and heart models. Traditional Aramchol formulation results in 80-90% accumulation in the liver and has limited effect on the heart. The new LPNs Aramchol formulation which selectively targets the heart tissue could potentially become a disease modifying therapy for cardiac fibrosis and unmet cardiac diseases. Galmed Pharmaceuticals Ltd. announced the breakthrough development of a new Aramchol-based lipid nanoparticles formulation (LNP) for targeted delivery to the heart. Further advancing the previously reported development of Aramchol's nanocarrier-enabled targeted formulations, Galmed has developed a novel LNP formulation of Aramchol, based on FDA approved lipids, that penetrates the heart tissue. The development work, a collaboration between Galmed and Barcode Nanotech, applies advanced formulation science, in vivo screening, and AI-enabled analysis which aims to identify optimal vehicles for precise cardiac delivery. The platform enables in vivo screening of hundreds of nanoparticle candidates to support the identification of formulations with potentially improved targeting, biodistribution, and functional performance. By adapting this platform to cardiac applications, the companies aim to develop cardiac-targeted therapies delivered through LNPs that can selectively engage relevant cell populations, including fibroblasts and other disease-driving cardiac cells. These efforts are intended to support both Aramchol-based cardiac programs and future therapeutic candidates built on the same delivery technology. Cardiac fibrosis is a major contributor to heart failure progression and remains an area of significant unmet medical need. Despite advances in cardiovascular care, no therapies directly prevent or reverse cardiac fibrosis, highlighting the need for novel therapeutic approaches. The goal of the Galmed – Barcode collaboration is to open a new route for disease-modifying therapies in cardiovascular medicine, where efficient and selective delivery to the heart tissue remains a major challenge. Barcode Nanotech has developed a library of novel lipids for RNA and DNA, LNP-based delivery, through a unique in vivo & AI-based screening platform which allow simultaneously screening of hundreds of different nanoparticle formulations. Our proprietary lipid library and screening platform capabilities enable the development of Aramchol's selective delivery LNP formulation to the heart. We now focus on the development of modified LNPs to target specific cardiac cell types. We believe this work may create the basis for a new generation of cardiac therapies, with Aramchol serving as an important first example of what our platform can achieve.