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SAN FRANCISCO – Results of a Phase 2b study, Aramchol, a stearoyl coenzyme desaturase A inhibitor, according to data from Liver Meeting 2018, liver oil and healed histology are important for excellent safety and tolerability in patients with nonalcoholic fatty liver disease. significantly reduced.
. Aramchol is a novel targeting liver to reduce liver fat and collagen production in the SCD1 modulator. “ Vlad Ratzi, MD In his presentation at the University of Sorbonne in France, he said. In In a 1-year study, Aramchol demonstrated liver fat reduction, biochemical recovery, NASH resolution and decreased fibrosis in the dose response model. “
To evaluate the safety and efficacy of Aramchol (aracholyl amido cholanoic acid; Galmed Pharmaceuticals) for liver fat reduction, Ratziu et al.
The researchers forced the patients to take either 400 mg (n = 101) or 600 mg (n = 98) Aramchol or placebo (n = 48). They evaluated liver fat by magnetic resonance spectroscopy.
At 1-year follow-up, liver oil decreased significantly in 400 mg group (PA = .045) and showed a nearly significant trend in the 600 mg group.PA <0.05) compared to placebo. The researchers found 47% of patients in the group of 600 mg, 47% in the group, 24% in the placebo group (OR = 2.77; 95% CI, 1.12-6.89), and 37%. They observed an absolute decrease in 37%. . The dose response was suggested, Rat Ratziu said.
Without worsening fibrosis, NASH resolution was more frequent in the 600 mg group than in the placebo group (16.7% vs. 5.7%; OR = 4.74; 95% CI, 0.99-22.66).
Both dose groups significantly reduced alanine aminotransferase (PA Aspartate aminotransferase (<.001)PA = .002) and HbA1c (PA <RTI ID = 11.2> <.001 </ RTI> compared with placebo in dose response.
Absence due to adverse events was below 5% and there were serious side effects in 10% of patients with no difference in dose groups. During the trial, the weight remained neutral and none of the patients had any changes in lipid parameters.
U The results put 600 mg of Aramchol among the advanced therapeutic candidates for NASH and support further testing in a phase 3 study, NAS Ratziu added.
Reference:
Ratziu V, et al. Summary LB-5. Presented in: Liver Meeting 2018; 9-13 November 2018; San Francisco.
Information: Ratziu, Galmed, Genfit, Gilead, Intercept and reported financial links with Novartis.
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