Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) announced results from its Phase 1 pharmacokinetics study showing that a 400mg dose of aramchol meglumine increased bioavailability approximately five-fold compared to 300mg aramchol free acid tablets.

The study, designated AM-001, evaluated single doses of aramchol meglumine granules for oral suspension at 400mg and 200mg compared to aramchol free acid 300mg tablets in healthy subjects. The new formulation allows for once-daily dosing versus the twice-daily regimen required for the previous formulation.

The company said the results enable production of a GMP clinical batch for upcoming trials and could reduce cost of goods by approximately 50%. An additional study comparing 400mg aramchol meglumine tablets once daily with 300mg aramchol free acid tablets twice daily is ongoing.

Aramchol works by down-regulating stearoyl CoA desaturase 1 in hepatocytes and hepatic stellate cells. The drug targets metabolic-dysfunction associated steatohepatitis, previously known as non-alcoholic steatohepatitis, a liver disease that can lead to cirrhosis and liver failure.

In previous Phase 2 and Phase 3 trials, 600mg aramchol reduced liver fat and demonstrated anti-fibrotic effects. Approximately 600 adults have received the drug to date, including 240 healthy subjects and 360 patients with MASH.

"A once daily lower dose of aramchol meglumine is advantageous for compliance as monotherapy or in combination with other MASH candidates," said Allen Baharaff, the company's co-founder and CEO.

Galmed is also evaluating aramchol in pre-clinical studies for gastrointestinal cancer treatments, seeking to enhance standard-of-care oncology agents and overcome drug resistance.