Galmed Pharmaceuticals announced positive results from a pharmacokinetic (PK) study showing that dose splitting of Aramchol 600mg to twice daily 300mg significantly increased plasma levels.
The aim of this Phase I, open-label, two-period, randomized, crossover PK study was to assess whether dose splitting of Aramchol 600mg to twice daily 300mg will significantly increase plasma levels. 16 healthy subjects took part in two study periods. Eight subjects received each regimen in the first period and the alternate regimen in the second period. A PK profile was obtained over the dosing interval at steady state on day ten of each period.
Results of the study showed that the administration of Aramchol 300 mg twice daily resulted in 24-hour plasma concentrations significantly greater than those observed with the administration of Aramchol 600 mg once daily (P<0.0001). The average plasma levels (exposure) were 53% higher and exposure was greater in all 16 subjects with the twice daily dosing. The treatment in both dosing regimens was similar in terms of safety and was well tolerated.
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"As previously seen in our presentations, a dose response pattern was observed in the recently completed Phase 2b ARREST study. Aramchol 600mg resulted in higher efficacy compared to 400mg, with only a 20% elevation in plasma levels. We find a further increase of 53% highly encouraging as this implies the potential for significantly higher efficacy on both NASH resolution and fibrosis improvement," stated Allen Baharaff, Chief Executive Officer of Galmed.
"The results of this study were recently obtained and submitted to the FDA. We are planning to discuss these new findings in our forthcoming end of Phase 2b meeting," added Mr. Baharaff.
Aramchol™ (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol™'s ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating down regulation of the three key pathologies of NASH; steatosis, inflammation and fibrosis. The effect of Aramchol™ on fibrosis is mediated by down regulation of steatosis and directly on human collagen producing cells. Aramchol™ has been granted by the FDA Fast Track designation status for the treatment of NASH.
NASH is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality.