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SAN FRANCISCO – The results of a phase 2b trial showed that Aramchol – stearoyl coenzyme desaturase A inhibitor – significantly reduced liver fat and improved histology with excellent safety and tolerability in patients with nonalcoholic fatty liver disease, according to data presented at The Liver Meeting 2018 .
"Aramchol is a novel, first-class SCD1 modulator, targeted to the liver to reduce liver fat and collagen production," Vlad Ratziu, MD, from Sorbonne University in France, said in his presentation. "In 1 year of study, Aramchol showed a reduction in liver fat, improved biochemistry, resolution of NASH and reduction in fibrosis in a dose response pattern."
To assess the safety and efficacy of Aramchol (arachidyl amido cholanoic acid; Galmed Pharmaceuticals) for reducing liver fat, Ratziu and colleagues enrolled 247 patients who were overweight or obese and prediabetes or diabetes who had a proven NASH biopsy.
The researchers randomly assigned patients to receive either 400 mg (n = 101) or 600 mg (n = 98) from Aramchol or placebo (n = 48). They assess liver fat by magnetic resonance spectroscopy.
At 1 year follow-up, liver fat was significantly reduced in the 400 mg group (P = .045) and showed an almost significant trend in the 600 mg group (P <.066) compared to placebo. The researchers observed absolute reductions from a 5% baseline or higher in 47% of patients in the 600 mg group vs. 24% in the placebo group (OR = 2.77; 95% CI, 1.12-6.89) and 37% at 400 mg, which "shows the dose response," Ratziu said.
NASH resolution without worsening fibrosis occurred more frequently in the 600 mg group than in the placebo group (16.7% vs 5%; OR = 4.74; 95% CI, 0.99-22.66).
Both dose groups experienced a significant reduction in alanine aminotransferase (P <.001), aspartate aminotransferase (P = .002) and HbA1c (P <.001) compared with placebo by dose response.
Termination due to side effects of less than 5% and serious side effects occur in 10% of patients without differences between dose groups. Weight remained neutral during the experiment and no patients experienced changes in lipid parameters.
"Aramchol's 600 mg results are among the advanced therapeutic candidates for NASH and support further testing in the phase 3 trial," concluded Ratziu.
Reference:
Ratziu V, et al. Abstract LB-5. Presented at: The Liver Meeting 2018; November 9-13 2018; San Francisco.
Disclosure: Ratziu reports on financial connections with Galmed, Genfit, Gilead, Intercept, and Novartis.
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