#Israel #Tel Aviv #NASH #Aramchol #Galmed

Galmed Pharmaceuticals Celebrates Progress in Clinical Trials

Galmed Pharmaceuticals Ltd., a biopharmaceutical company recognized for its innovative approaches in liver and cardiometabolic health, has announced promising preliminary data from Part 1 of the AM-001 study. This study focuses on Aramchol Meglumine, a newly enhanced formulation of its leading candidate, Aramchol, recognized for its potential as a SCD1 inhibitor. The AM-001 study marks an essential phase in Galmed's journey as they transition towards the more effective formulation of this already advanced therapeutic.

The AM-001 study involved comparing the bioavailability of Aramchol Meglumine with its predecessor, Aramchol acid, in healthy volunteers. Initial findings have been overwhelmingly positive, showing that a single dose of 400 mg of Aramchol Meglumine resulted in an area under the curve (AUC) nearly double that of equivalent doses of Aramchol acid. These results not only suggest that 200 mg is likely the optimal dose for future trials but also indicate significant improvements in patient compliance. The switch from a twice-daily to a once-daily dosing regimen is expected to enhance adherence in treatment, making it a more user-friendly option, which could lead to better health outcomes.

Allen Baharaff, President and CEO of Galmed Pharmaceuticals, emphasized the distinctive advantages that Aramchol Meglumine offers compared to Aramchol acid, including its improved solubility and systemic exposure. The enhancement in bioavailability is a game-changer, particularly for patients suffering from NASH, or Non-Alcoholic Steatohepatitis, which constitutes a significant part of the liver disease landscape. This compound's ability to regulate SCD-1 makes it a promising candidate for broader cardiometabolic applications and certain oncological conditions.

Moreover, the new formulation holds patent protection until 2035, ensuring that Galmed maintains its competitive edge while advancing its clinical programs. The FDA's approval for transitioning Aramchol acid to Aramchol Meglumine under a new IND was a crucial step, allowing Galmed to build upon the substantial preclinical and clinical data collected over recent years.

As the study continues into its second phase, which is expected to wrap up in late 2025, the Galmed team remains diligent in its commitment to accelerating the clinical development of Aramchol Meglumine. The long patent duration and the promising results from early trials position the company favorably, suggesting a robust potential for market growth and therapeutic advancement.

The implications of these results are significant, providing hope not just for patients with NASH, but also signaling potential for innovative treatments in gastrointestinal oncology. Galmed is set on developing therapies that adequately address unmet medical needs in these critical areas, thereby ensuring valuable returns for stakeholders and healthier futures for patients.

As the research progresses, Galmed aims to explore diverse applications of Aramchol Meglumine, continuously seeking ways to enhance its product pipeline and align with its core expertise in developing life-changing therapies. With such advancements, Galmed stands out as a beacon of hope and innovation within the biopharmaceutical industry.

Summary of Upcoming Milestones

• - Part 1 of AM-001 shows positive preliminary results.
• - Transition from Aramchol to Aramchol Meglumine approved by the FDA.
• - Phase 2 study timelines expected to conclude in 2025.
• - Continued commitment to exploring cardiometabolic and oncological applications.

As Galmed continues to pave its path through rigorous research and development, the scientific community and patients alike eagerly anticipate the next steps in its quest for groundbreaking therapies. With dedicated efforts and emergent findings, Galmed Pharmaceuticals exemplifies the intersection of science and hope in modern medicine.