Galmed Pharmaceuticals has announced positive preliminary results from Part 1 of its Phase 1 bioavailability study (AM-001) for Aramchol Meglumine, an enhanced formulation of the company's lead compound for liver, cardiometabolic, and gastrointestinal oncology indications.
The study revealed that a 400mg dose of Aramchol Meglumine suspension achieved an area under the curve (AUC) nearly double that of Aramchol acid tablets, indicating significantly improved bioavailability. Based on these findings, researchers have identified 200mg once-daily as the optimal dosing regimen for future clinical trials.
"Aramchol is the most advanced down regulator of SCD-1 (Stearoyl-CoA desaturase) in clinical development," said Allen Baharaff, President and CEO of Galmed Pharmaceuticals. "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."
Enhanced Formulation Advantages
The N-methylglucamine (meglumine) salt of Aramchol represents a significant improvement over the original Aramchol acid formulation, offering enhanced solubility, absorption, and systemic exposure. These properties translate to higher bioavailability, which could potentially improve efficacy at lower doses.
The U.S. Food and Drug Administration (FDA) previously approved Galmed's transition from Aramchol acid to Aramchol Meglumine under a new Investigational New Drug (IND) application. This approval leveraged cross-references to substantial preclinical and clinical data accumulated for Aramchol acid, with the bioavailability study being the only additional requirement for the transition.
Importantly, Aramchol Meglumine has received New Chemical Entity (NCE) patent protection extending until 2035, providing Galmed with a lengthy runway for clinical development and potential commercialization.
Clinical Development Background
Galmed has successfully advanced the original Aramchol acid formulation through six clinical trials, including Phase 3 studies, enrolling a total of 661 subjects. These trials established both the overall safety profile of the compound and its efficacy in treating non-alcoholic steatohepatitis (NASH), now known as metabolic dysfunction-associated steatohepatitis (MASH).
The AM-001 study consists of two parts comparing single doses of Aramchol acid and Aramchol Meglumine in healthy volunteers. Part 2 of the study is expected to conclude in the second half of 2025.
Practical Benefits for Patients and Manufacturers
The simplified dosing regimen—moving from twice-daily to once-daily administration—is expected to improve patient adherence to treatment. Additionally, the lower optimal dose (200mg) could potentially reduce the overall cost of goods for manufacturing.
"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," Baharaff added.
Strategic Implications
These positive results represent a pivotal milestone in Galmed's transition to Aramchol Meglumine as its lead compound in advanced clinical development. The company is positioning the improved formulation for development both as a standalone agent and in novel drug combinations for multiple indications influenced by fatty acid metabolism.
By following the path of other biopharmaceutical companies that have successfully introduced improved formulations, Galmed believes that Aramchol Meglumine's enhanced bioavailability, once-daily dosing, and robust patent protection position the company favorably for continued growth and development.
Looking Forward
With Part 1 of the AM-001 study showing promising results, Galmed is committed to accelerating Aramchol Meglumine's clinical program. The company aims to leverage these findings to advance the compound into Phase 2 studies for various indications beyond NASH and fibrosis, including cardiometabolic diseases and gastrointestinal cancers.
As Galmed builds on its strong clinical foundation, the company is focused on delivering innovative therapies for patients with significant unmet medical needs while creating value for stakeholders through this improved formulation of its lead compound.
