Galmed Pharmaceuticals Achieves Major Milestone with AM-001 Study Results
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 14 2026
0mins
Source: PRnewswire
- Dose Optimization: The AM-001 study demonstrates that a single 400mg dose of Aramchol meglumine has approximately 5-fold greater bioavailability compared to 300mg of Aramchol free acid dosed twice daily, significantly enhancing drug efficacy and providing better treatment options for MASH patients.
- Clinical Trial Progress: To date, around 600 adults have received single or multiple doses of Aramchol, including 240 healthy subjects and 360 MASH patients, indicating good tolerability and potential efficacy across different populations.
- Therapeutic Potential: Aramchol has shown significant anti-fibrotic effects in clinical trials, effectively reducing liver fat and alleviating steatohepatitis, further solidifying Galmed's market position in liver disease treatment.
- Future Development Directions: Galmed plans to evaluate Aramchol in multiple pre-clinical studies for combination therapies to overcome drug resistance and enhance efficacy in GI cancer treatments, showcasing the company's strategic positioning in liver and oncology therapies.
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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 Achieves Major Milestone with AM-001 Study Results
- Dose Optimization: The AM-001 study demonstrates that a single 400mg dose of Aramchol meglumine has approximately 5-fold greater bioavailability compared to 300mg of Aramchol free acid dosed twice daily, significantly enhancing drug efficacy and providing better treatment options for MASH patients.
- Clinical Trial Progress: To date, around 600 adults have received single or multiple doses of Aramchol, including 240 healthy subjects and 360 MASH patients, indicating good tolerability and potential efficacy across different populations.
- Therapeutic Potential: Aramchol has shown significant anti-fibrotic effects in clinical trials, effectively reducing liver fat and alleviating steatohepatitis, further solidifying Galmed's market position in liver disease treatment.
- Future Development Directions: Galmed plans to evaluate Aramchol in multiple pre-clinical studies for combination therapies to overcome drug resistance and enhance efficacy in GI cancer treatments, showcasing the company's strategic positioning in liver and oncology therapies.
See More
Development of Novel Cardiac Fibrosis Model Announced
- Collaborative Model Development: Tissue Dynamics and Galmed Pharmaceuticals are collaborating to develop a novel human chronic cardiac fibrosis model aimed at accelerating the discovery and development of Aramchol-based therapies, particularly for complex diseases like post-myocardial infarction remodeling and heart failure.
- Cardiovascular Disease Burden: Cardiovascular diseases remain the leading cause of death globally, projected to account for 20.5 million deaths by 2025, highlighting a significant market need as there are currently no effective therapies that can directly reverse cardiac fibrosis.
- Technological Innovation: The new platform will integrate Tissue Dynamics' highly physiological vascularized multichambered cardiac organoids with embedded metabolic sensors, capable of testing over 20,000 organoids simultaneously, capturing real-time functional kinetics to provide more human-relevant insights into cardiac disease treatment.
- Strategic Implications: By enabling real-time monitoring and AI-driven analysis, this model is expected to support rapid evaluation of Aramchol candidates, potentially transforming the development of cardiac fibrosis therapies by improving tissue repair and addressing underlying metabolic dysfunction.
See More
Tissue Dynamics and Galmed Collaborate on Cardiac Fibrosis Model Development
- Collaborative Model Development: Tissue Dynamics and Galmed Pharmaceuticals are collaborating to develop a novel human chronic cardiac fibrosis model aimed at accelerating the discovery and development of Aramchol-based therapies, which is expected to significantly enhance the efficiency of cardiac disease treatments.
- Impact of Cardiac Fibrosis: Cardiac fibrosis is a major driver of chronic heart failure, with cardiovascular diseases accounting for approximately 20.5 million deaths annually worldwide, making the development of effective therapies crucial for public health.
- Innovative Technology Application: The new platform will combine Tissue Dynamics' multichambered cardiac organoids with embedded metabolic sensors, capable of testing over 20,000 organoids simultaneously, capturing real-time functional kinetics data, thus advancing cardiac disease research.
- Strategic Implications: This collaboration will leverage Galmed's expertise in SCD1 biology and metabolic pathway modulation, while AI-driven analysis will support rapid evaluation of Aramchol candidates, potentially transforming the development of cardiac fibrosis therapies.
See More
Galmed Partners with Tel Aviv University to Develop New Therapy
- Collaboration Agreement: Galmed Pharmaceuticals has signed a collaboration agreement with Ramot at Tel Aviv University to evaluate the potential of Aramchol in treating metastatic brain cancer, marking a strategic expansion into oncology.
- Drug Mechanism Analysis: Originally developed as an SCD1 inhibitor for liver disease, Aramchol is now being repurposed for breast cancer brain metastasis treatment, demonstrating its potential by downregulating SCD1 to prevent further metastasis in cancer cells.
- Research Support: Studies from Tel Aviv University indicate that p53 mutations lead to metabolic adaptations associated with SCD1 upregulation, and Galmed plans to validate Aramchol's efficacy in p53-deficient brain metastasis using advanced preclinical testing systems.
- Clinical Work Advancement: This collaboration will support Galmed's ongoing clinical research at Virginia Commonwealth University, particularly in colorectal cancers where p53 mutations are prevalent, providing a new research direction for Aramchol's application.
See More
Galmed Partners with Tel Aviv University to Develop New Cancer Therapy
- Research Collaboration Agreement: Galmed Pharmaceuticals has signed a research collaboration agreement with Ramot at Tel Aviv University to evaluate its brain-penetrating SCD1 inhibitor, Aramchol, as a targeted therapy for metastatic brain cancer, marking a strategic expansion into cancer treatment.
- Combining Genomics and Modeling: By collaborating with the Ben-David Lab and Satchi-Fainaro Lab, Galmed aims to leverage advanced 3D in vitro and in vivo modeling techniques to validate Aramchol's efficacy in treating p53-deficient brain metastases, potentially providing critical data support for clinical applications.
- Metabolic Adaptation Research: Studies indicate that p53 inactivation induces metabolic adaptations in tumors, facilitating metastasis in the lipid-rich brain microenvironment, and Aramchol's downregulation of SCD1 could represent a novel treatment option for this metabolic-dependent brain tumor, holding significant clinical implications.
- Innovative Treatment Prospects: Galmed CEO Allen Baharaff emphasized that the discovery of p53 inactivation driving brain metastasis opens up innovative therapeutic opportunities for Aramchol, and this collaboration will advance its development in metastatic cancers, addressing the high unmet needs of patient populations.
See More
Galmed Partners with Tel Aviv University to Develop Aramchol for Brain Metastases
- Breakthrough in Drug Development: Galmed announced a collaboration with Ramot at Tel Aviv University to utilize Aramchol as a first-in-class brain-penetrant SCD1 inhibitor targeting metastatic brain cancer, potentially offering an innovative therapy for this lethal condition.
- Survival Rate Challenge: Patients with brain metastases have a two-year survival rate below 10%, and despite various treatment modalities, there is an urgent need for new therapies, making the development of Aramchol crucial for improving outcomes.
- Research Collaboration Advantage: By leveraging the genomic expertise of the Ben-David Lab and the 3D modeling capabilities of the Satchi-Fainaro Lab, Galmed aims to validate Aramchol's efficacy in treating p53-deficient brain metastases, paving the way for clinical applications.
- Strategic Significance: This collaboration not only lays the groundwork for Aramchol's clinical development but also may provide new therapeutic insights for other cancer types, highlighting Galmed's innovative potential in oncology.
See More
Galmed Pharmaceuticals Achieves Major Milestone with AM-001 Study Results
- Dose Optimization: The AM-001 study demonstrates that a single 400mg dose of Aramchol meglumine has approximately 5-fold greater bioavailability compared to 300mg of Aramchol free acid dosed twice daily, significantly enhancing drug efficacy and providing better treatment options for MASH patients.
- Clinical Trial Progress: To date, around 600 adults have received single or multiple doses of Aramchol, including 240 healthy subjects and 360 MASH patients, indicating good tolerability and potential efficacy across different populations.
- Therapeutic Potential: Aramchol has shown significant anti-fibrotic effects in clinical trials, effectively reducing liver fat and alleviating steatohepatitis, further solidifying Galmed's market position in liver disease treatment.
- Future Development Directions: Galmed plans to evaluate Aramchol in multiple pre-clinical studies for combination therapies to overcome drug resistance and enhance efficacy in GI cancer treatments, showcasing the company's strategic positioning in liver and oncology therapies.
See More
Development of Novel Cardiac Fibrosis Model Announced
- Collaborative Model Development: Tissue Dynamics and Galmed Pharmaceuticals are collaborating to develop a novel human chronic cardiac fibrosis model aimed at accelerating the discovery and development of Aramchol-based therapies, particularly for complex diseases like post-myocardial infarction remodeling and heart failure.
- Cardiovascular Disease Burden: Cardiovascular diseases remain the leading cause of death globally, projected to account for 20.5 million deaths by 2025, highlighting a significant market need as there are currently no effective therapies that can directly reverse cardiac fibrosis.
- Technological Innovation: The new platform will integrate Tissue Dynamics' highly physiological vascularized multichambered cardiac organoids with embedded metabolic sensors, capable of testing over 20,000 organoids simultaneously, capturing real-time functional kinetics to provide more human-relevant insights into cardiac disease treatment.
- Strategic Implications: By enabling real-time monitoring and AI-driven analysis, this model is expected to support rapid evaluation of Aramchol candidates, potentially transforming the development of cardiac fibrosis therapies by improving tissue repair and addressing underlying metabolic dysfunction.
See More
Tissue Dynamics and Galmed Collaborate on Cardiac Fibrosis Model Development
- Collaborative Model Development: Tissue Dynamics and Galmed Pharmaceuticals are collaborating to develop a novel human chronic cardiac fibrosis model aimed at accelerating the discovery and development of Aramchol-based therapies, which is expected to significantly enhance the efficiency of cardiac disease treatments.
- Impact of Cardiac Fibrosis: Cardiac fibrosis is a major driver of chronic heart failure, with cardiovascular diseases accounting for approximately 20.5 million deaths annually worldwide, making the development of effective therapies crucial for public health.
- Innovative Technology Application: The new platform will combine Tissue Dynamics' multichambered cardiac organoids with embedded metabolic sensors, capable of testing over 20,000 organoids simultaneously, capturing real-time functional kinetics data, thus advancing cardiac disease research.
- Strategic Implications: This collaboration will leverage Galmed's expertise in SCD1 biology and metabolic pathway modulation, while AI-driven analysis will support rapid evaluation of Aramchol candidates, potentially transforming the development of cardiac fibrosis therapies.
See More
Galmed Partners with Tel Aviv University to Develop New Therapy
- Collaboration Agreement: Galmed Pharmaceuticals has signed a collaboration agreement with Ramot at Tel Aviv University to evaluate the potential of Aramchol in treating metastatic brain cancer, marking a strategic expansion into oncology.
- Drug Mechanism Analysis: Originally developed as an SCD1 inhibitor for liver disease, Aramchol is now being repurposed for breast cancer brain metastasis treatment, demonstrating its potential by downregulating SCD1 to prevent further metastasis in cancer cells.
- Research Support: Studies from Tel Aviv University indicate that p53 mutations lead to metabolic adaptations associated with SCD1 upregulation, and Galmed plans to validate Aramchol's efficacy in p53-deficient brain metastasis using advanced preclinical testing systems.
- Clinical Work Advancement: This collaboration will support Galmed's ongoing clinical research at Virginia Commonwealth University, particularly in colorectal cancers where p53 mutations are prevalent, providing a new research direction for Aramchol's application.
See More
Galmed Partners with Tel Aviv University to Develop New Cancer Therapy
- Research Collaboration Agreement: Galmed Pharmaceuticals has signed a research collaboration agreement with Ramot at Tel Aviv University to evaluate its brain-penetrating SCD1 inhibitor, Aramchol, as a targeted therapy for metastatic brain cancer, marking a strategic expansion into cancer treatment.
- Combining Genomics and Modeling: By collaborating with the Ben-David Lab and Satchi-Fainaro Lab, Galmed aims to leverage advanced 3D in vitro and in vivo modeling techniques to validate Aramchol's efficacy in treating p53-deficient brain metastases, potentially providing critical data support for clinical applications.
- Metabolic Adaptation Research: Studies indicate that p53 inactivation induces metabolic adaptations in tumors, facilitating metastasis in the lipid-rich brain microenvironment, and Aramchol's downregulation of SCD1 could represent a novel treatment option for this metabolic-dependent brain tumor, holding significant clinical implications.
- Innovative Treatment Prospects: Galmed CEO Allen Baharaff emphasized that the discovery of p53 inactivation driving brain metastasis opens up innovative therapeutic opportunities for Aramchol, and this collaboration will advance its development in metastatic cancers, addressing the high unmet needs of patient populations.
See More
Galmed Partners with Tel Aviv University to Develop Aramchol for Brain Metastases
- Breakthrough in Drug Development: Galmed announced a collaboration with Ramot at Tel Aviv University to utilize Aramchol as a first-in-class brain-penetrant SCD1 inhibitor targeting metastatic brain cancer, potentially offering an innovative therapy for this lethal condition.
- Survival Rate Challenge: Patients with brain metastases have a two-year survival rate below 10%, and despite various treatment modalities, there is an urgent need for new therapies, making the development of Aramchol crucial for improving outcomes.
- Research Collaboration Advantage: By leveraging the genomic expertise of the Ben-David Lab and the 3D modeling capabilities of the Satchi-Fainaro Lab, Galmed aims to validate Aramchol's efficacy in treating p53-deficient brain metastases, paving the way for clinical applications.
- Strategic Significance: This collaboration not only lays the groundwork for Aramchol's clinical development but also may provide new therapeutic insights for other cancer types, highlighting Galmed's innovative potential in oncology.
See More
