There appears to be some more good news in the fight against fatty liver. The U.S. Food and Drug Administration (FDA) has supported Galmed Pharmaceutical Ltd. in a limited clinical pharmacology study plan with respect to Aramchol meglumine. Aramchol (or arachidyl amido cholanoic acid) is described as a novel fatty acid bile acid conjugate, liver targeted SCD1 modulator. It was developed as an oral therapy to treat nonalcoholic steatohepatitis (NASH) and fibrosis.
According to the company’s press release, and based on clinical data from its ongoing open-label part of the Phase 3 ARMOR study, the randomized, double-blind, placebo-controlled part of the Phase 3 study will be conducted with the Aramchol meglumine once daily regimen.
Galmed Pharmaceuticals Ltd. is in Israel-based biopharma outfit targeting liver, metabolic and inflammatory diseases. The small company also said the agreement with the FDA is without a need to conduct additional nonclinical and clinical studies, other than planned limited pharmacology studies relating to Aramchol meglumine.
NASH is still rather unmet and undertreated in medical settings. It is believed to impact 3% to 5% of the U.S. population alone. It is also estimated to impact 2% to 4% globally, and it is considered to be the fastest growing cause of liver cancer and liver transplants.
A rise in obesity is a leading issue causing NASH. And while this is liver-related, NASH can also contribute toward cardiovascular disease, as well as cirrhosis of the liver and liver-related mortality.
The company’s press release noted that Aramchol is an improved salt form compound with significantly greater water solubility than the free acid and an NCE patent protection valid until December 2034. It is also represented to contain the same active pharmaceutical ingredient.
There are two meaningful ways that Aramchol is shown to benefit patients so far in its study. The first is achieving the required exposure with 50% less API as well as significantly reducing its target marketing price once Aramchol is approved via the potential saving of ~50% of COGs in developing a NASH treatment. The company also went on to note that the transition to Aramchol meglumine is the final step in the company’s drug product optimization.
Galmed’s press release said:
Aramchol’s ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol has been granted Fast Track Designation status by the FDA for the treatment of NASH.