Galmed Collaborates with Tel Aviv University on Aramchol for Brain Cancer
Galmed Pharmaceuticals announced a research collaboration agreement with Ramot at Tel Aviv University to evaluate Galmed's brain-penetrating SCD1 inhibitor, Aramchol, as a targeted therapy for metastatic brain cancer. By combining the genomic expertise of the Ben-David Lab with the advanced 3D in vitro and in vivo modeling capabilities of the Satchi-Fainaro Lab, Galmed aims to validate Aramchol's efficacy in treating p53-deficient brain metastases. The findings from the new research would also support Galmed's clinical work underway at Virginia Commonwealth University's Massey Comprehensive Cancer Center in colorectal cancers, where p53 mutations are highly prevalent. The published research by Prof. Ben-David and Prof. Satchi-Fainaro demonstrated that the loss of p53 induces profound metabolic adaptations of the tumor, facilitating metastatic colonization in the lipid-rich brain microenvironment. SCD1, an enzyme that converts saturated fatty acids into monounsaturated fatty acids, is essential for lipid synthesis and membrane production in proliferating cancer cells. Owing to SCD1 upregulation in p53-deficient tumors, its downregulation by Aramchol could potentially treat the metabolic-dependent brain tumor, as confirmed in preclinical models. The collaboration is managed by Ramot, Tel Aviv University's technology transfer company. Ramot is dedicated to bringing the groundbreaking research of Prof. Uri Ben-David and Prof. Ronit Satchi-Fainaro to the clinic. Their work on the metabolic vulnerabilities of p53-deficient tumors represents a transformative approach to treating metastatic brain cancer, offering a new path for patients with high unmet needs.
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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.
- 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.
- 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.
- 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.
- 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.
- 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.










