Galimedix Reports Excellent Phase 1 Results for GAL-101 with No Adverse Events
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 04 2025
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Source: Globenewswire
- 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.
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About GLMD
Galmed Pharmaceuticals Ltd. is an Israel-based biopharmaceutical company dedicated to the development of therapeutics for the treatment of liver diseases. The Company is focused its research and development efforts on addressing unmet medical needs in the field of liver health. The Company's flagship product is Aramchol, a first-in-class synthetic fatty acid-bile acid conjugate molecule. Aramchol is aimed to be effective in the treatment of non-alcoholic steatohepatitis (NASH) in patients who are overweight or obese and have prediabetes or type II diabetes mellitus. The Company's drug aims to be efficient treatment of NASH, a chronic liver disease characterized by fat accumulation, inflammation, and fibrosis, which can lead to cirrhosis and liver cancer if left untreated.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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.
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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.
Continue Reading