– AM-001 Study represents a pivotal milestone in Galmed’s transition to Aramchol Meglumine, an improved formulation of its lead compound in advanced clinical development
– Aramchol Meglumine, a New Chemical Entity (NCE) protected by patents until 2035, is being developed both as a standalone agent and in novel drug combinations for multiple indications influenced by fatty acid metabolism
– Initial findings suggest that the new Aramchol Meglumine formulation offers higher bioavailability than Aramchol free acid and that a once-daily, oral 200 mg dose is likely to be optimal for future trials, supporting improved patient compliance and potentially lowering manufacturing costs
TEL AVIV, Israel — Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and gastrointestinal oncology indications, today announced positive preliminary results from Part 1 of the Ph1 Bioavailability AM-001 Study of Aramchol Meglumine.
Galmed has successfully advanced Aramchol acid through six clinical trials (up to Ph3) enrolling 661 subjects, establishing both its overall safety and its efficacy in treating NASH (MASH). The N-methylglucamine (meglumine) salt of Aramchol exhibits notable advantages over Aramchol acid, including enhanced solubility, absorption, and systemic exposure, translating to higher bioavailability. In recognition of these benefits, Aramchol Meglumine received NCE patent protection extending until 2035.
Previously, the FDA approved the transition from Aramchol acid to Aramchol Meglumine under a new IND, leveraging cross-reference to the substantial preclinical and clinical data amassed in recent years for Aramchol. The only requirement for this transition was a bioavailability study to compare the two formulations.
The AM-001 study was conducted in response to that FDA request and is also designed to help identify the doses best suited for advancing Aramchol Meglumine into Phase 2 studies. It consists of two parts, comparing single doses of Aramchol acid and Aramchol Meglumine in healthy volunteers. Part 2 of the study is anticipated to conclude in the second half of 2025.
In Part 1 of AM-001, preliminary results demonstrate that a 400 mg dose of Aramchol Meglumine suspension achieved an area under the curve (AUC) nearly double that of Aramchol acid tablets. Based on these outcomes, 200 mg once daily appears to be the optimal dose for subsequent clinical trials. This once-daily regimen not only simplifies patient adherence (moving from twice-daily to once-daily) but is also expected to reduce the overall cost of goods.
“Aramchol is the most advanced down regulator of SCD-1 (Stearoyl – CoA desaturase) in clinical development. Inhibition of SCD-1 has been recently investigated in multiple indications, re-emphasizing its metabolic master switch potential and importance in multiple organs and functions. We expect that the long patent runway of Aramchol Meglumine will allow us to develop the full therapeutical potential of the drug in the planned expansion in cardiometabolic diseases and gastrointestinal cancers we recently announced,” said Allen Baharaff, President and CEO of Galmed Pharmaceuticals.
These latest Part 1 data reinforce Galmed’s commitment to accelerating Aramchol Meglumine’s clinical program. As seen with other biopharmaceutical companies that have successfully introduced improved formulations—often resulting in increased market interest—Galmed believes that Aramchol Meglumine’s enhanced bioavailability, once-daily dosing, and robust patent protection position the Company favorably for continued growth. By building on its strong clinical foundation, Galmed aims to deliver innovative therapies for patients with significant unmet medical needs, while responsibly driving value for stakeholders.
About Galmed Pharmaceuticals Ltd.
We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver disease and we are currently seeking to advance the development of Aramchol for oncological indications outside of NASH and fibrosis. In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development.
Investor and Media Contact
Guy Nehemya, Chief Operating Officer
investor.relations@galmedpharma.com