Galmed Announces Milestone Results from Phase 1 PK Study of Aramchol
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 14 2026
0mins
Galmed announced milestone results from a Phase 1 PK study in healthy subjects. The overall objective of the study was to identify the dose of Aramchol meglumine - AM - administered once daily that produces similar exposure to Aramchol from 300mg Aramchol free acid - AA - tablets dosed twice daily. Single doses of AM granules for oral suspension of 400 mg and 200mg were evaluated and compared to AA 300mg tablet. The study demonstrated that the bioavailability of Aramchol from the Aramchol meglumine granules for oral suspension is considerably greater than that from Aramchol free acid tablets. An additional PK study comparing AM 400mg tablets once daily with AA 300mg tablets twice daily is ongoing. In Phase 2 and Phase 3 clinical trials 600mg Aramchol reduced liver fat, attenuated steatohepatitis and demonstrated robust anti-fibrotic effects. MASH, previously called non-alcoholic steatohepatitis or NASH, is a common serious type of fatty liver disease often leading to cirrhosis, liver failure and sometimes to hepatocellular carcinoma. To date ~ 600 adults have received single or multiple doses of Aramchol free acid, including ~240 healthy subjects and 360 patients with MASH.
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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.
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- Significant Drug Combination Effects: The combination of Aramchol Meglumine and a selective PPARα agonist reduced fibrotic burden by approximately fourfold (p<0.001) in inflammatory human cardiac organoids, preserving cardiac muscle integrity and maintaining metabolic function, indicating its potential in cardiac fibrosis treatment.
- Clinical Development Prospects: Following the study results, Tissue Dynamics has filed a new patent and is preparing for future IND-enabling activities, highlighting the company's innovative capabilities and market potential in cardiac disease treatment.
- Strategic Collaboration Significance: The partnership between Galmed and Tissue Dynamics aims to leverage advanced AI technologies and human organoid models to advance research and development in cardiometabolic diseases, potentially providing more therapeutic options for fibrotic diseases and enhancing the company's competitiveness in the biopharmaceutical sector.
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- New Mechanism Discovery: Tissue Dynamics identified a previously unrecognized metabolic mechanism driving cardiac fibrosis using human cardiac organoid models, providing new insights into disease biology that could facilitate the development of novel therapies.
- Significant Treatment Effects: The combination of Aramchol Meglumine and a selective PPARα agonist reduced fibrotic burden by approximately fourfold (p<0.001) in inflammatory human cardiac organoids while preserving cardiac muscle integrity and metabolic function, indicating its potential in treating cardiac fibrosis.
- Clinical Development Prospects: Following the study's findings, Tissue Dynamics has filed a new patent application and is preparing for future IND-enabling activities, which will pave the way for new clinical development pathways for cardiac fibrosis and related diseases.
- Deepening Strategic Collaboration: The partnership between Galmed Pharmaceuticals and Tissue Dynamics is set to enhance its R&D strategy, leveraging advanced AI technologies and human organoid models to identify additional therapeutic opportunities for fibrotic diseases, thereby strengthening the company's competitive position in the cardiometabolic field.
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- 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.
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- 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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- 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.
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- New Mechanism Discovery: Tissue Dynamics identified an unrecognized metabolic mechanism driving cardiac fibrosis using human cardiac organoid models, providing a new biological perspective for treating heart diseases that could potentially alter existing treatment strategies.
- Significant Drug Combination Effects: The combination of Aramchol Meglumine and a selective PPARα agonist reduced fibrotic burden by approximately fourfold (p<0.001) in inflammatory human cardiac organoids, preserving cardiac muscle integrity and maintaining metabolic function, indicating its potential in cardiac fibrosis treatment.
- Clinical Development Prospects: Following the study results, Tissue Dynamics has filed a new patent and is preparing for future IND-enabling activities, highlighting the company's innovative capabilities and market potential in cardiac disease treatment.
- Strategic Collaboration Significance: The partnership between Galmed and Tissue Dynamics aims to leverage advanced AI technologies and human organoid models to advance research and development in cardiometabolic diseases, potentially providing more therapeutic options for fibrotic diseases and enhancing the company's competitiveness in the biopharmaceutical sector.
See More
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- New Mechanism Discovery: Tissue Dynamics identified a previously unrecognized metabolic mechanism driving cardiac fibrosis using human cardiac organoid models, providing new insights into disease biology that could facilitate the development of novel therapies.
- Significant Treatment Effects: The combination of Aramchol Meglumine and a selective PPARα agonist reduced fibrotic burden by approximately fourfold (p<0.001) in inflammatory human cardiac organoids while preserving cardiac muscle integrity and metabolic function, indicating its potential in treating cardiac fibrosis.
- Clinical Development Prospects: Following the study's findings, Tissue Dynamics has filed a new patent application and is preparing for future IND-enabling activities, which will pave the way for new clinical development pathways for cardiac fibrosis and related diseases.
- Deepening Strategic Collaboration: The partnership between Galmed Pharmaceuticals and Tissue Dynamics is set to enhance its R&D strategy, leveraging advanced AI technologies and human organoid models to identify additional therapeutic opportunities for fibrotic diseases, thereby strengthening the company's competitive position in the cardiometabolic field.
See More
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- 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
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- 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
