Galmed announces significant findings from AM-001 study of Aramchol meglumine
Study Results: Galmed Pharmaceuticals reported significant top-line results from the AM-001 Phase 1 Bioavailability Study of Aramchol meglumine, showing that its bioavailability (BA) is significantly higher than that of Aramchol free acid tablets.
Dosing Insights: The study indicated that the BA of 400mg and 200mg Aramchol meglumine granules was approximately 5-fold and 3-fold greater, respectively, compared to the 300 mg Aramchol free acid tablets.
Clinical Progress: Galmed has successfully advanced Aramchol through six clinical trials, including Phase 3, with a total of 661 patients enrolled, demonstrating its safety and efficacy in treating NASH.
Regulatory Pathway: To date, 82 healthy subjects have received Aramchol meglumine under a clinical trial application in the UK, as part of the IND 505(b)1 regulatory pathway.
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Galmed Pharmaceuticals to Initiate Phase 1/2 Trial of Aramchol and Regorafenib in 2026
- Clinical Trial Launch: Galmed Pharmaceuticals announced the initiation of a Phase 1/2 clinical trial for the combination of Aramchol and Regorafenib in 2026, aimed at enhancing treatment efficacy for hepatocellular carcinoma and other GI cancers, marking a significant advancement in the company's liver disease treatment efforts.
- Scientific Rationale Strengthened: Research indicates that Aramchol significantly enhances Bayer's Regorafenib efficacy in GI cancer models through SCD1 inhibition, providing a solid scientific foundation for the upcoming clinical trial.
- Investor Value Enhancement: Positive outcomes from the clinical trial could lay the groundwork for expanding Galmed's oncology pipeline, potentially attracting more investor interest and increasing the company's overall market value.
- Industry Recognition: The acceptance of Galmed's latest research findings at the HEP-DART 2025 meeting underscores the significance of its work in liver disease treatment, further enhancing the company's competitive position in the market.

Galimedix Reports Excellent Phase 1 Results for GAL-101 with No Adverse Events
- Clinical Trial Success: Galimedix presented Phase 1 study results for GAL-101 at CTAD 2025, involving approximately 100 healthy volunteers, demonstrating excellent safety and tolerability with no dose-limiting adverse events, indicating the drug's potential in Alzheimer's treatment.
- Drug Penetration Capability: GAL-101 confirmed effective blood-brain barrier penetration with lumbar CSF concentrations after multiple doses, supporting a once-daily dosing regimen for future trials, which may enhance patient adherence to treatment.
- Future Research Planning: Following positive Phase 1 results, Galimedix is planning a Phase 2 proof-of-concept study in Alzheimer's disease, expected to include cognitive functional endpoints and biomarkers to capture early signs of cognitive improvement.
- Technological Innovation: As a small molecule targeting misfolded amyloid beta monomers to prevent toxic aggregate formation, GAL-101 shows broad application prospects in treating Alzheimer's disease, dry age-related macular degeneration, and glaucoma.








