Monday , March 8 2021

Aramchol reduces liver oil, improves histology NASH



SAN FRANCISCO – Phase 2b study showed that Aramchol – a stearoyl coenzyme desaturase A inhibitor – significantly reduced liver oil and improved histology, providing excellent safety and tolerability in patients with non-alcoholic fatty liver disease, according to data submitted in the 2018 Liverum meeting.

"Aramchol is the first-class SCD1 modulator for the liver to reduce liver and collagen production" Vlad Ratziu, MD from the University of Sorbonne in France, said in a presentation. "In one study, Aramchol showed decreased liver fat, biochemical improvement, NASH resolution and decreased fibrosis in the dose response model."

In order to assess the safety and efficacy of Aramchol (arachidyl amido cholanoic acid, Galmed Pharmaceuticals) in reducing liver oil, Ratziu and his colleagues participated in 247 overweight or obese patients and prediabetes or diabetes who had undergone a NASH biopsy.

The researchers randomly assigned either 400 mg (n = 101) or 600 mg (n = 98) Aramchol or placebo (n = 48) to patients. They evaluated liver magnetic resonance spectroscopy.

After 1 year of observation, the liver fat in the 400 mg group significantly decreased (P = 0.045) and found an almost significant trend in the 600 mg group (P <.066) versus placebo. The researchers observed an absolute reduction from baseline of 5% or more in 47% of the patients in the 600 mg group, compared to 24% in the placebo group (OR = 2.77, 95% CI, 1.12-6.89) and 37% in the 400 mg group, respectively. which "suggests a dose response," said Rathieu.

NASH resistance without fibrosis worsening was more common in the 600 mg group than in the placebo group (16.7% vs. 5%, OR = 4.74, 95% CI, 0.99-22.66).

In both dose groups, alanine aminotransferase (P <.001), aspartate aminotransferase (P = .002) and HbA1c (P <.001) compared to the placebo dose response.

The discontinuation of adverse drug reactions was less than 5%, and serious adverse reactions were observed in 10% of patients without differences in dosage groups. During the trial, weight remained neutral and patients had no change in lipid parameters.

"The results place Aramchol 600 mg among the progressive therapeutic candidates of NASH and promote additional testing in Phase 3 study," concluded Ratziu.

Reference:

Ratziu V et al. Abstract LB-5. Filed under: 2018 Liver Meeting; 9-13 October 2018 November; San francisco

Disclosure: Ratzu reports on financial connections with Gallet, Genfit, Gilead, Interceptu and Novartis.


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