RAMAT-GAN, Israel, May 14, 2026
Galmed Pharmaceuticals Ltd. announced positive results from its first-in-human pharmacokinetics study evaluating the oral formulation of Aramchol Meglumine (AM), revealing that the investigational therapy achieved an approximately 500% increase in bioavailability compared with the company’s earlier Aramchol free acid (AA) formulation. The findings from the Phase 1 AM-001 study represent a significant development for Galmed’s liver disease and gastrointestinal oncology pipeline, potentially enabling once-daily dosing, improved patient compliance, reduced manufacturing costs, and expanded therapeutic applications in both MASH and GI cancers.
Phase 1 Study Demonstrates Significant Pharmacokinetic Improvement
According to Galmed, the AM-001 study was designed to identify a once-daily dose of Aramchol meglumine capable of delivering exposure levels comparable to the previously used twice-daily 300 mg Aramchol free acid tablets. The study evaluated single oral doses of 400 mg and 200 mg AM granules in healthy volunteers and compared the pharmacokinetic profile against the standard AA formulation. Results demonstrated that the 400 mg AM formulation achieved approximately five-fold greater bioavailability, while the 200 mg formulation achieved approximately three-fold greater bioavailability than the older Aramchol free acid tablets.
The company noted that the transition to a once-daily lower dose regimen could provide several major advantages, including the production of GMP clinical batches for upcoming clinical trials, extension of intellectual property protection, a projected 50% reduction in drug cost of goods, and enhanced convenience for patients if commercialized. Galmed also confirmed that an additional pharmacokinetic study, known as AM-003, is currently underway to compare once-daily AM 400 mg tablets directly against twice-daily AA 300 mg tablets.
Aramchol Expands Beyond MASH Into GI Oncology
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Aramchol is designed to down-regulate stearoyl CoA desaturase 1 (SCD1) in hepatocytes, hepatic stellate cells, and other tissues, including several cancer types. The therapy has primarily been developed for metabolic dysfunction-associated steatohepatitis (MASH), previously known as non-alcoholic steatohepatitis (NASH), a progressive fatty liver disease that can lead to cirrhosis, liver failure, and hepatocellular carcinoma.
Galmed highlighted that previous Phase 2 and Phase 3 open-label studies demonstrated that 600 mg Aramchol reduced liver fat accumulation, attenuated steatohepatitis, and produced strong anti-fibrotic effects in MASH patients. To date, approximately 600 adults have received single or multiple doses of Aramchol free acid, including healthy volunteers and patients with MASH, supporting the therapy’s broader clinical development strategy.
The company is now positioning Aramchol for broader gastrointestinal and oncological applications. Galmed stated that the therapy is being evaluated in multiple preclinical studies aimed at overcoming drug resistance and enhancing the efficacy of standard-of-care oncology agents in GI cancers. The higher drug exposure achieved with the AM formulation may support expanded use beyond liver disease into oncology-focused therapeutic combinations.
Galmed Strengthens Long-Term GI Therapeutics Strategy
Allen Baharaff, Galmed’s Co-founder and Chief Executive Officer, described the once-daily lower-dose formulation as an important advancement for patient convenience and combination treatment potential. He stated that the increased exposure achieved with Aramchol meglumine could help unlock the therapy’s broader multi-system therapeutic potential across GI diseases and cancers.
Galmed is continuing to expand its development strategy beyond liver disease into cardiometabolic, neurological, and gastrointestinal oncology indications. The company emphasized that the pharmacokinetic improvements demonstrated in AM-001 strengthen its long-term positioning within the GI therapeutics market while supporting future regulatory and commercial development activities.
The latest results come at a time when the pharmaceutical industry is intensifying efforts to develop more effective treatments for MASH and GI cancers, two therapeutic areas with substantial unmet medical need and rapidly growing commercial interest worldwide.
Source: Galmed Pharmaceuticals press release
